Device recall: Rhythm Xience Guider Catheter Introducer with Lancer Intergrated Dilator/Transseptal Needle, Ref 112852, Sterile EO…
Class II FDA enforcement event 85197. Recall start date: . Status in the FDA record: Terminated. Termination date: .
Reason for recall, in the words of FDA
It has been determined that the manufacturing process may have left foreign material particulates on the finished device. This could result in a range of event from procedure delay to pulmonary embolism.
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
Acutus Medical Inc started this device recall on 25 Feb 2020. The firm address in the FDA record is in Carlsbad, CA. FDA put the recall in Class II. FDA event 85197 has 4 product records. The first FDA enforcement report date is 29 Apr 2020. The record gives the status Terminated, with the termination date 27 Apr 2021.
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.
US: CA,SC, AZ OUS: None
Recalling firm
Acutus Medical Inc, Carlsbad, CA.
Recalling firm: The firm that the FDA record names for a recall.
FDA records how the recall started: Voluntary: Firm initiated.
Products
4 product records in the event.
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-1768-2020 | Rhythm Xience Guider Catheter Introducer with Lancer Intergrated Dilator/Transseptal Needle, Ref 112852, Sterile EO, RxOnly | 108 units | Class II | Terminated | 29 Apr 2020 |
| Z-1769-2020 | Acutus Medical AcQGuide Mini Fixed-Curve Introducer with AcQCros QX Integrated Dilator/Transseptal Needle, Ref: 112852 Sterile EO, RxOnly | 268 units | Class II | Terminated | 29 Apr 2020 |
| Z-1770-2020 | Rhythm Xience Flextra Steerable Introducer with Lancer Integrated Dilator/Transseptal Needle, REF: 122852, Sterile EO, RxOnly | 30 units | Class II | Terminated | 29 Apr 2020 |
| Z-1771-2020 | Acutus Medical AcQGuide Flex Steerable Introducer with AcQcross QX Integrated Dilator/Transseptal Needle, REF: 122852, SterileEO RxOnly | 5 units | Class II | Terminated | 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
- 4
- Events of the firm on the register
- 1
Official channels
- FDA enforcement report Z-1768-2020The 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.
Follow by RSS:Food, drug and device recallsFDA Class I recalls
Cite this page
Recall Register. FDA enforcement event 85197. https://recallregister.com/fda/ii/85197/. 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:
US: CA,SC, AZ OUS: None
- What quantity of product is in FDA event 85197?
- The event has 4 product records. The first record gives this quantity:
108 units
- 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.