A component maker's recall reached 32,934 finished units — 107 records name a supplier (Oscor)
The U.S. FDA classified 32,934 introducer kits made by Oscor Inc. for the Impella heart pump as Class I — its most serious category — because manufacturing issues may allow the sheath to leak. The record lists distribution to a single state, Massachusetts.
Recall overview (primary data)
- ClassificationClass I (most serious)
- Product typeMedical Device
- Recalling firmOscor Inc.
- ReasonDue 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.
- DistributionDistribution in the US state of MA
- Recall initiated2026-06-10
Key points
- Recall number Z-2680-2026; FDA Class I, the most serious category; status Ongoing.
- The product is the "Hemostatic Peel Away Introducer System with Infusion Sideport, 23F" for Impella (Abiomed REF: 0052-3006).
- The reason is potential leakage from manufacturing issues — at the sidearm, under the sheath cap, and along the hub score lines (14Fr and 23Fr).
- Quantity 32,934 units; distribution recorded only for Massachusetts, suggesting supply as a component to a finished-device maker.
- Voluntary, firm-initiated. Initiated 2026-06-10; reported 2026-07-22.
- Of the 1,408 FDA recall records this site holds as of 2026-09-01, 107 name a supplier in the reason, 92 of them devices.
1What an introducer is
An introducer creates the entry point for putting a thin tube or a device into a blood vessel. It consists of a tubular sheath that holds open the path from the skin to the vessel, together with the parts that help place it. The kit covered here is used to insert Impella, a circulatory support pump that temporarily assists the work of the heart, through a vessel.
A leaking sheath means that blood or infused fluid may escape from a pathway that is supposed to stay closed.
2The record names where the leak could occur
The FDA record is specific about the locations at risk: the sidearm, under the sheath cap, and along the hub score lines. The hub is the connector at the proximal end of the device, and score lines are the ridges left by molding. The cause is described as manufacturing issues, and two sizes are affected, 14Fr and 23Fr.
Fr (French) is the unit for the outer diameter of catheter-type devices; a larger number means a larger diameter.
3What distribution to a single state means
The quantity is large at 32,934 units, yet distribution is recorded only for the U.S. state of Massachusetts. That suggests the product does not go directly to hospitals but is supplied as a component to a finished-device manufacturer based in that state. Indeed, several Class I recalls citing leakage in the same 14Fr and 23Fr introducers were recorded around the same time by Abiomed, Inc., which is located in Massachusetts.
4One hundred and seven records name a supplier
Of the 1,408 FDA recall records this site holds as of 2026-09-01, 107 name a supplier in the reason for recall, and 92 of those are devices.
A problem arising in a part or an ingredient surfaces as a recall of the finished product built around it. The firm named in the record is usually the one that filed for the finished product, so where the cause sits can only be read from the reason text. A case like this one, filed by the component maker itself, is where that relationship comes into view.
Why it matters
A recall on the component side can be large in quantity yet nearly invisible to clinical sites, because distribution stops at the finished-device maker. What hospitals need to follow is the notice on the finished product, and keeping lot numbers and UDI in the device register determines how quickly affected units can be found. For manufacturers, the key preparation is records that immediately show which of their own finished lots a component recall reaches.
FAQ
What is an introducer?
Why is distribution limited to one state?
What do "14Fr" and "23Fr" mean?
Sources (primary)
Source: openFDA (U.S. FDA, CC0 public domain). Data is provided as-is and must not be used for medical decisions. Verify the latest and exact details with the official FDA recall information. This site is not endorsed or certified by the U.S. FDA.
- FDA recall information (official)
- openFDA (data provider)
- Recall number: Z-2680-2026