Device recall: Abiomed REF: 0052-3025, Introducer Kit for Impella Hemostatic Peel Away Introducer System with Infusion Sideport, 14F…
Class I FDA enforcement event 99102. Recall start date: . Status in the FDA record: Ongoing.
Reason for recall, in the words of FDA
Due to manufacturing issues, there is a potential for the 14Fr and 23Fr introducer sheaths to leak from the sidearm, under the sheath cap, and along the hub score lines in the hub region.
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
Oscor Inc. started this device recall on 10 Jun 2026. The firm address in the FDA record is in Palm Harbor, FL. FDA put the recall in Class I. FDA event 99102 has 3 product records. The first FDA enforcement report date is 22 Jul 2026. 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.
Distribution in the US state of MA
Recalling firm
Oscor Inc., Palm Harbor, FL.
Recalling firm: The firm that the FDA record names for a recall.
FDA records how the recall started: Voluntary: Firm initiated.
Products
3 product records in the event.
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-2678-2026 | Abiomed REF: 0052-3025, Introducer Kit for Impella Hemostatic Peel Away Introducer System with Infusion Sideport, 14F 13cm and 25cm. heart pump and accessories. | 355 units | Class I | Ongoing | 22 Jul 2026 |
| Z-2679-2026 | Abiomed REF: 0052-3021, Introducer Kit for Impella Hemostatic Peel Away Introducer System with Infusion Sideport, 14F, 23F. heart pump and accessories. | 1332 units | Class I | Ongoing | 22 Jul 2026 |
| Z-2680-2026 | Abiomed REF: 0052-3006, Introducer Kit for Impella Hemostatic Peel Away Introducer System with Infusion Sideport, 23F. heart pump and accessories. | 32,934 units | Class I | Ongoing | 22 Jul 2026 |
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 2026
- 572
- Share of these events in Class I
- 12%
- Product records in this event
- 3Median of the firm: 1
- Events of the firm on the register
- 7
Other events of the firm
| Initiated | Product (first record) | Type | Class | Records |
|---|---|---|---|---|
| 22 Dec 2021 | Destino Twist 14F (also branded as Guidestar 14F) | Device | Class II | 1 |
| 10 Mar 2021 | AngioDynamics SafeSheath ULTRALITE 10F, Model Number VI10 - Product Usage: intended for the introduction of various type | Device | Class II | 1 |
| 26 Sep 2018 | TB Series Bipolar Pacing Leads, French Size 4F, 5F, 6F for Curve Type Straight, Atrial J, 60 degree Curve, and Right Hea | Device | Class I | 1 |
| 31 Mar 2017 | ATAR Reusable Extension Cable, sold under brand names: ATAR Reusable Series, ATAR 53912 Reusable Series, and XI Reusable | Device | Class I | 2 |
| 5 Oct 2016 | OSCOR ADELANTE BREEZEWAY 8F C55¿ S61CM D66CM Catalog # AB081040 Is designed to facilitate the introduction of catheters | Device | Class II | 30 |
| 25 Jul 2012 | Myocardial Heart Wires Intended for temporary atrial and ventricular pacing and sensing during or after cardiac surgery | Device | Class II | 1 |
Official channels
- FDA enforcement report Z-2678-2026The 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 99102. https://recallregister.com/fda/i/99102/. 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:
Distribution in the US state of MA
- What quantity of product is in FDA event 99102?
- The event has 3 product records. The first record gives this quantity:
355 units
- How did the recall start?
- The FDA record says:
Voluntary: Firm initiated
- How many device recalls of 2026 have the same class?
- 12% of the 572 device events that started in 2026 are in Class I.