Device recall: SHERPA NX ACTIVE GUIDING CATHETER, 6F, IMA 55CM .070", REF SA6IMAK. for cardiovascular use
Class I FDA enforcement event 82525. Recall start date: . Status in the FDA record: Completed. Termination date: .
Reason for recall, in the words of FDA
There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.
Class I, in the words of FDA
a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death
The recalling firm started this device recall on 15 Mar 2019. The FDA record names a person as the firm, and this site does not show the name. The firm address in the FDA record is in Danvers, MA. FDA put the recall in Class I. FDA event 82525 has 191 product records. The first FDA enforcement report date is 9 Oct 2019. The record gives the status Completed, with the termination date 26 Apr 2024.
It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.
FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on . openFDA export of .
Distribution
In the words of FDA.
Worldwide distribution to US, Austria, Belgium, Bulgaria, Czech Republic, France, Germany, Greece, Hong Kong, Ireland, Italy, Kazakhstan, Luxembourg, Moldova, Netherlands, Poland, Portugal, Russian…
Recalling firm
The name is withheld, Danvers, MA.
The FDA record gives the name of a person as the recalling firm. This site does not show the names of persons.
Recalling firm: The firm that the FDA record names for a recall.
FDA records how the recall started: Voluntary: Firm initiated.
Products
191 product records in the event.
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-2562-2019 | SHERPA NX ACTIVE GUIDING CATHETER, 6F, IMA 55CM .070", REF SA6IMAK. for cardiovascular use | 1226 units | Class I | Completed | 9 Oct 2019 |
| Z-2563-2019 | SHERPA NX ACTIVE GUIDING CATHETER, 6F, RDND1 55CM .070", REF SA6RDND1K. for cardiovascular use | 658 units | Class I | Completed | 9 Oct 2019 |
| Z-2564-2019 | SHERPA NX ACTIVE GUIDING CATHETER, 6F, 3DRC 100CM .070", REF SA63DRC. for cardiovascular use | 538 units | Class I | Completed | 9 Oct 2019 |
| Z-2565-2019 | SHERPA NX ACTIVE GUIDING CATHETER, 6F, AL1.0 110CM .070", REF SA6AL10A. for cardiovascular use | 12 units | Class I | Completed | 9 Oct 2019 |
| Z-2566-2019 | SHERPA NX ACTIVE GUIDING CATHETER, 6F, AL1.0 90CM.070", REF SA6AL10D. for cardiovascular use | 4 units | Class I | Completed | 9 Oct 2019 |
| Z-2567-2019 | SHERPA NX ACTIVE GUIDING CATHETER, 6F, AL3.0 110CM.070", REF SA6AL30A. for cardiovascular use | 1 unit | Class I | Completed | 9 Oct 2019 |
| Z-2568-2019 | SHERPA NX ACTIVE GUIDING CATHETER, 6F, AL.75 110CM.070", REF SA6AL75A. for cardiovascular use | 12 units | Class I | Completed | 9 Oct 2019 |
| Z-2569-2019 | SHERPA NX ACTIVE GUIDING CATHETER, 6F, AR1.0 100CM.070", REF SA6AR10. for cardiovascular use | 1491 units | Class I | Completed | 9 Oct 2019 |
| Z-2570-2019 | SHERPA NX ACTIVE GUIDING CATHETER, 6F, AR1.0SH 100CM.070", REF SA6AR10SH. for cardiovascular use | 655 units | Class I | Completed | 9 Oct 2019 |
| Z-2571-2019 | SHERPA NX ACTIVE GUIDING CATHETER, 6F, AR2.0, 100CM.070", REF SA6AR20. for cardiovascular use | 1701 units | Class I | Completed | 9 Oct 2019 |
| Z-2572-2019 | SHERPA NX ACTIVE GUIDING CATHETER, 6F, AR2.0 SH, 100CM.070", REF SA6AR20SH. for cardiovascular use | 221 units | Class I | Completed | 9 Oct 2019 |
| Z-2573-2019 | SHERPA NX ACTIVE GUIDING CATHETER, 6F, CHAMP0.5, 100CM.070", REF SA6CHAMP05. for cardiovascular use | 29 units | Class I | Completed | 9 Oct 2019 |
| Z-2574-2019 | SHERPA NX ACTIVE GUIDING CATHETER, 6F, CHAMP0.5 SH, 100CM.070", REF SA6CHAMP05SH. for cardiovascular use | 6 units | Class I | Completed | 9 Oct 2019 |
| Z-2575-2019 | SHERPA NX ACTIVE GUIDING CATHETER, 6F, CHAMP2.0, 55CM.070", REF SA6CHAMP20K. for cardiovascular use | 5 units | Class I | Completed | 9 Oct 2019 |
| Z-2576-2019 | SHERPA NX ACTIVE GUIDING CATHETER, 6F, EBU3.5, 110CM.070", REF SA6EBU35A. for cardiovascular use | 18 units | Class I | Completed | 9 Oct 2019 |
| Z-2577-2019 | SHERPA NX ACTIVE GUIDING CATHETER, 6F, EBU3.5, 90CM.070", REF SA6EBU35D. for cardiovascular use | 2 units | Class I | Completed | 9 Oct 2019 |
| Z-2578-2019 | SHERPA NX ACTIVE GUIDING CATHETER, 6F, EBU4.0, 110CM.070", REF SA6EBU40A. for cardiovascular use | 17 units | Class I | Completed | 9 Oct 2019 |
| Z-2579-2019 | SHERPA NX ACTIVE GUIDING CATHETER, 6F, FL4.0, 100CM.070", REF SA6FL40. for cardiovascular use | 20 units | Class I | Completed | 9 Oct 2019 |
| Z-2580-2019 | SHERPA NX ACTIVE GUIDING CATHETER, 6F, FL4.0 SH, 100CM, 070", REF SA6FL40SH. for cardiovascular use | 9 units | Class I | Completed | 9 Oct 2019 |
| Z-2581-2019 | SHERPA NX ACTIVE GUIDING CATHETER, 6F, HSI, 100CM, 070", REF SA6HSI. for cardiovascular use | 215 units | Class I | Completed | 9 Oct 2019 |
| Z-2582-2019 | SHERPA NX ACTIVE GUIDING CATHETER, 6F, HSI SH, 100CM, 070", REF SA6HSISH . for cardiovascular use | 14 units | Class I | Completed | 9 Oct 2019 |
| Z-2583-2019 | SHERPA NX ACTIVE GUIDING CATHETER, 6F, IMA, 100CM, 070", REF SA6IMA. for cardiovascular use | 555 units | Class I | Completed | 9 Oct 2019 |
| Z-2584-2019 | SHERPA NX ACTIVE GUIDING CATHETER, 6F, IMA, 90CM, 070", REF SA6IMAD . for cardiovascular use | 53 units | Class I | Completed | 9 Oct 2019 |
| Z-2585-2019 | SHERPA NX ACTIVE GUIDING CATHETER, 6F, IMA SH, 100CM, 070", REF SA6IMASH. for cardiovascular use | 42 units | Class I | Completed | 9 Oct 2019 |
| Z-2586-2019 | SHERPA NX ACTIVE GUIDING CATHETER, 6F, IMA SH, 60CM, 070", REF SA6IMASHJ. for cardiovascular use | 2 units | Class I | Completed | 9 Oct 2019 |
| Z-2587-2019 | SHERPA NX ACTIVE GUIDING CATHETER, 6F, JCR4.0, 100CM, 070", REF SA6JCR40. for cardiovascular use | 27 units | Class I | Completed | 9 Oct 2019 |
| Z-2588-2019 | SHERPA NX ACTIVE GUIDING CATHETER, 6F, JL3.5, 110CM, 070", REF SA6JL35A. for cardiovascular use | 12 units | Class I | Completed | 9 Oct 2019 |
| Z-2589-2019 | SHERPA NX ACTIVE GUIDING CATHETER, 6F, JL4.0, 110CM, 070", REF SA6JL40A. for cardiovascular use | 22 units | Class I | Completed | 9 Oct 2019 |
| Z-2590-2019 | SHERPA NX ACTIVE GUIDING CATHETER, 6F, JL4.0, 90CM, 070", REF SA6JL40D. for cardiovascular use | 14 units | Class I | Completed | 9 Oct 2019 |
| Z-2591-2019 | SHERPA NX ACTIVE GUIDING CATHETER, 6F, JL5.0, 110CM, 070", REF SA6JL50A. for cardiovascular use | 12 units | Class I | Completed | 9 Oct 2019 |
| Z-2592-2019 | SHERPA NX ACTIVE GUIDING CATHETER, 6F, JR4.0, 110CM, 070", REF SA6JR40A. for cardiovascular use | 10 units | Class I | Completed | 9 Oct 2019 |
| Z-2593-2019 | SHERPA NX ACTIVE GUIDING CATHETER, 6F, JR4.0, 90CM, 070", REF SA6JR40D. for cardiovascular use | 5 units | Class I | Completed | 9 Oct 2019 |
| Z-2594-2019 | SHERPA NX ACTIVE GUIDING CATHETER, 6F, JR4.0, 55CM, 070", REF SA6JR40K. for cardiovascular use | 39 units | Class I | Completed | 9 Oct 2019 |
| Z-2595-2019 | SHERPA NX ACTIVE GUIDING CATHETER, 6F, LCB SH, 90CM, 070", REF SA6LCBSHD. for cardiovascular use | 2 units | Class I | Completed | 9 Oct 2019 |
| Z-2596-2019 | SHERPA NX ACTIVE GUIDING CATHETER, 6F, MB1, 90CM, 070", REF SA6MB1D. for cardiovascular use | 6 units | Class I | Completed | 9 Oct 2019 |
| Z-2597-2019 | SHERPA NX ACTIVE GUIDING CATHETER, 6F, MP1, 55CM, 070", REF SA6MP1K. for cardiovascular use | 0 units | Class I | Completed | 9 Oct 2019 |
| Z-2598-2019 | SHERPA NX ACTIVE GUIDING CATHETER, 6F, MPH, 55CM, 070", REF SA6MPHK. for cardiovascular use | 8 units | Class I | Completed | 9 Oct 2019 |
| Z-2599-2019 | SHERPA NX ACTIVE GUIDING CATHETER, 6F, NOTO, 100CM, 070", REF SA6NOTO. for cardiovascular use | 20 units | Class I | Completed | 9 Oct 2019 |
| Z-2600-2019 | SHERPA NX ACTIVE GUIDING CATHETER, 6F, NOTO SH, 100CM, 070", REF SA6NOTOSH. for cardiovascular use | 4 units | Class I | Completed | 9 Oct 2019 |
| Z-2601-2019 | SHERPA NX ACTIVE GUIDING CATHETER, 6F, PK1, 47CM, 070", REF SA6PK1W. for cardiovascular use | 10 units | Class I | Completed | 9 Oct 2019 |
| Z-2602-2019 | SHERPA NX ACTIVE GUIDING CATHETER, 6F, RBU3.5, 100CM, 070", REF SA6RBU35. for cardiovascular use | 172 units | Class I | Completed | 9 Oct 2019 |
| Z-2603-2019 | SHERPA NX ACTIVE GUIDING CATHETER, 6F, RBU3.5 SH, 100CM, 070", REF SA6RBU35SH. for cardiovascular use | 55 units | Class I | Completed | 9 Oct 2019 |
| Z-2604-2019 | SHERPA NX ACTIVE GUIDING CATHETER, 6F, RCB, 90CM, 070", REF SA6RCBD. for cardiovascular use | 1 unit | Class I | Completed | 9 Oct 2019 |
| Z-2605-2019 | SHERPA NX ACTIVE GUIDING CATHETER, 6F, RCB SH, 90CM, 070", REF SA6RCBSHD. for cardiovascular use | 2 units | Class I | Completed | 9 Oct 2019 |
| Z-2606-2019 | SHERPA NX ACTIVE GUIDING CATHETER, 6F, RDC, 55CM, 070", REF SA6RDCK. for cardiovascular use | 49 units | Class I | Completed | 9 Oct 2019 |
| Z-2607-2019 | SHERPA NX ACTIVE GUIDING CATHETER, 6F, SR3.0, 100CM, 070", REF SA6SR30. for cardiovascular use | 4 units | Class I | Completed | 9 Oct 2019 |
| Z-2608-2019 | SHERPA NX ACTIVE GUIDING CATHETER, 6F, SR4.0, 100CM, 070", REF SA6SR40. for cardiovascular use | 8 units | Class I | Completed | 9 Oct 2019 |
| Z-2609-2019 | SHERPA NX ACTIVE GUIDING CATHETER, 6F, SR4.0 SH, 100CM, 070", REF SA6SR40SH. for cardiovascular use | 0 units | Class I | Completed | 9 Oct 2019 |
| Z-2610-2019 | SHERPA NX ACTIVE GUIDING CATHETER, 6F 100CM 3DRC, REF SA63DRCSH. for cardiovascular use | 246 units | Class I | Completed | 9 Oct 2019 |
| Z-2611-2019 | SHERPA NX ACTIVE GUIDING CATHETER, 6F 110CM AL20, REF SA6AL20A. for cardiovascular use | 3 units | Class I | Completed | 9 Oct 2019 |
| Z-2612-2019 | SHERPA NX ACTIVE GUIDING CATHETER, 6F JR4.0 SH, 110CM, .070" REF SA6JR40SHA. for cardiovascular use | 1 unit | Class I | Completed | 9 Oct 2019 |
| Z-2613-2019 | SHERPA NX ACTIVE GUIDING CATHETER, 6F SR3.5, .070" REF SA6SR35. for cardiovascular use | 6 units | Class I | Completed | 9 Oct 2019 |
| Z-2614-2019 | SHERPA NX ACTIVE GUIDING CATHETER, 6F SR3.5 SH, .070" REF SA6SR35SH. for cardiovascular use | 4 units | Class I | Completed | 9 Oct 2019 |
| Z-2615-2019 | SHERPA NX ACTIVE GUIDING CATHETER, 6F EBU3.75, .070", REF SA6EBU375. for cardiovascular use | 6871 units | Class I | Completed | 9 Oct 2019 |
| Z-2616-2019 | SHERPA NX ACTIVE GUIDING CATHETER, 6F JL4.0, .070", REF SA6JL40. for cardiovascular use | 8966 units | Class I | Completed | 9 Oct 2019 |
| Z-2617-2019 | SHERPA NX ACTIVE GUIDING CATHETER, 6F EBU3.5, .070", REF SA6EBU35. for cardiovascular use | 32484 units | Class I | Completed | 9 Oct 2019 |
| Z-2618-2019 | SHERPA NX ACTIVE GUIDING CATHETER, 6F JR4.0, .070", REF SA6JR40. for cardiovascular use | 15603 units | Class I | Completed | 9 Oct 2019 |
| Z-2619-2019 | SHERPA NX ACTIVE GUIDING CATHETER, 6F JL3.5, .070", REF SA6JL35. for cardiovascular use | 6219 units | Class I | Completed | 9 Oct 2019 |
| Z-2620-2019 | SHERPA NX ACTIVE GUIDING CATHETER, 6F JL3.0, .070", REF SA6JL30. for cardiovascular use | 524 units | Class I | Completed | 9 Oct 2019 |
| Z-2621-2019 | SHERPA NX ACTIVE GUIDING CATHETER, 6F EBU4.0, .070", REF SA6EBU40. for cardiovascular use | 7839 units | Class I | Completed | 9 Oct 2019 |
The table shows 60 of 191 product records. The FDA enforcement report lists all the records.
openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports.
Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.
Enforcement report: The FDA publication that lists recalls. It has one record for each product of a recall.
Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.
Class I: The highest of the three FDA recall classes.
The event in context
- Device events that started in 2019
- 968
- Share of these events in Class I
- 6%
- Product records in this event
- 191
Official channels
- FDA enforcement report Z-2562-2019The FDA record of the first product of this event.
- FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
- FDA MedWatchThe FDA safety reporting program for drugs and medical devices.
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Cite this page
Recall Register. FDA enforcement event 82525. https://recallregister.com/fda/i/82525/. Source: openFDA enforcement reports. Data through .
Sources
- Source
- openFDA device enforcement reports
- Licence
- CC0 1.0
- Export date
- 28 Sep 2026
- Newest FDA report date on the register
- 23 Sep 2026
FDA has one record for each product. This site puts the records with the same event number on one page. The class of the event is the highest class of its records. How the register is made. Report an error.
Questions
- Where was the product distributed?
- The FDA record gives this distribution:
Worldwide distribution to US, Austria, Belgium, Bulgaria, Czech Republic, France, Germany, Greece, Hong Kong, Ireland, Italy, Kazakhstan, Luxembourg, Moldova, Netherlands, Poland, Portugal, Russian…
- What quantity of product is in FDA event 82525?
- The event has 191 product records. The first record gives this quantity:
1226 units
- How did the recall start?
- The FDA record says:
Voluntary: Firm initiated
- How many device recalls of 2019 have the same class?
- 6% of the 968 device events that started in 2019 are in Class I.