Device recall: Sensor Nitinol Wire with Hydrophilic Tip .035 3CM FLEX STR/150CM UPN: M0066703051 box 5 UPN: M0066703050 single unit
Class II FDA enforcement event 85227. Recall start date: . Status in the FDA record: Ongoing.
Reason for recall, in the words of FDA
An increase in the rate of complaints for difficulty or inability to track over the guidewire, may result in a procedural delay due to the need to exchange the affected device
Class II, in the words of FDA
a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
The recalling firm started this device recall on 9 Mar 2020. 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 Marlborough, MA. FDA put the recall in Class II. FDA event 85227 has 12 product records. The first FDA enforcement report date is 29 Apr 2020. The record gives the status Ongoing.
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.
Nationwide Foreign: Europe, Middle East and Africa, the Americas (North America and South America, Asia Pacific and Japan
Recalling firm
The name is withheld, Marlborough, 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
12 product records in the event.
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-1729-2020 | Sensor Nitinol Wire with Hydrophilic Tip .035 3CM FLEX STR/150CM UPN: M0066703051 box 5 UPN: M0066703050 single unit | 25,956 | Class II | Ongoing | 29 Apr 2020 |
| Z-1730-2020 | Sensor Nitinol Wire with Hydrophilic Tip .035 3CM FLEX /150CM UPN: M0066703061 box 5 UPN: M0066703060 single unit | 1,785 | Class II | Ongoing | 29 Apr 2020 |
| Z-1731-2020 | Sensor Nitinol Wire with Hydrophilic Tip .038 3CM FLEX STR/150CM UPN: M006670309 1box 5 UPN: M0066703090 single unit | 5,565 | Class II | Ongoing | 29 Apr 2020 |
| Z-1732-2020 | Sensor Nitinol Wire with Hydrophilic Tip .0383CM FLEX ANG/150CM UPN: M0066703101 box 5 UPN: M0066703100 single unit | 225 | Class II | Ongoing | 29 Apr 2020 |
| Z-1733-2020 | Percuflex Plus Ureteral Stent Set 6FX24CM with .038 Sensor UPN: M006175262110 | 91 units | Class II | Ongoing | 29 Apr 2020 |
| Z-1734-2020 | Percuflex Plus Ureteral Stent Set 6FX26CM with .038 Sensor UPN: M006175263110 | 32 | Class II | Ongoing | 29 Apr 2020 |
| Z-1735-2020 | Percuflex Plus Ureteral Stent Set 7FX24CM with .035 Sensor UPN: M006175272080 (edited 1/13/2021) | 5 units | Class II | Ongoing | 29 Apr 2020 |
| Z-1736-2020 | Contour VL Ureteral Stent Set 6FX22-30CM with .035 Sensor UPN: M006180156080 | 2 units | Class II | Ongoing | 29 Apr 2020 |
| Z-1737-2020 | Stretch VL Ureteral Stent Set 4.8FX22-30CM with .035 Sensor UPN: M006185155080 | 57 units | Class II | Ongoing | 29 Apr 2020 |
| Z-1738-2020 | Stretch VL Ureteral Stent Set 6FX22- 30CM with .035 Sensor UPN: M006185156080 | 50 units | Class II | Ongoing | 29 Apr 2020 |
| Z-1739-2020 | Stretch VL Ureteral Stent Set 7FX22-30CM with .035 Sensor UPN: M006185157080 | 40 units | Class II | Ongoing | 29 Apr 2020 |
| Z-1740-2020 | Polaris Ultra Ureteral Stent Set 6FX24CM with .035 Sensor UPN: M006192132080 | 19 units | Class II | Ongoing | 29 Apr 2020 |
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 II: The middle of the three FDA recall classes.
The event in context
- Device events that started in 2020
- 916
- Share of these events in Class II
- 93%
- Product records in this event
- 12
Official channels
- FDA enforcement report Z-1729-2020The 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 85227. https://recallregister.com/fda/ii/85227/. 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:
Nationwide Foreign: Europe, Middle East and Africa, the Americas (North America and South America, Asia Pacific and Japan
- What quantity of product is in FDA event 85227?
- The event has 12 product records. The first record gives this quantity:
25,956
- How did the recall start?
- The FDA record says:
Voluntary: Firm initiated
- How many device recalls of 2020 have the same class?
- 93% of the 916 device events that started in 2020 are in Class II.