CLASS I ONGOING Device recall · Reported 22 Jul 2026 · FDA Enforcement Report

Abiomed REF: 0052-3025, Introducer Kit for Impella Hemostatic Peel recalled

Oscor is recalling Abiomed REF: 0052-3025, Introducer Kit for Impella Hemostatic Peel, distributed in Massachusetts. The recall was initiated on 10 Jun 2026 and the FDA has classified it as Class I.

Check your package

Lot, batch or date codesAll Lots within Expiry/GTIN:00885672009793, 00813502010664

Quantity recalled355 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-2678-2026
FDA event ID: 99102
Recalling firm: Oscor, Palm Harbor, FL
Classification: Class I
Status: Ongoing
Recall initiated: 10 Jun 2026
FDA classified: 10 Jul 2026
Reported: 22 Jul 2026
Type: Voluntary: Firm initiated
Reason category: Packaging Defects
Device type: Heart & Vascular Devices

Timeline

10 Jun 2026	Recall initiated by company
10 Jul 2026	Classified by FDA	+30 days
22 Jul 2026	Published in enforcement report	+12 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

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.

Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.

Product as listed by the FDA

Abiomed REF: 0052-3025, Introducer Kit for Impella Hemostatic Peel Away Introducer System with Infusion Sideport, 14F 13cm and 25cm. heart pump and accessories.

Where it was distributed

Distribution in the US state of MA

Massachusetts

Questions about this recall

Why was it recalled?

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.

Which lots are affected?

All Lots within Expiry/GTIN:00885672009793, 00813502010664

Where was it sold?

Distribution in the US state of MA

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class I mean?

Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

2 other products · FDA event 99102

Reported	Class	Recall	Company	Reason	Where
22 Jul 2026	CLASS I	Abiomed REF: 0052-3021, Introducer Kit for Impella Hemostatic Peel recalled	Oscor	Packaging Defects	MA
22 Jul 2026	CLASS I	Abiomed REF: 0052-3006, Introducer Kit for Impella Hemostatic Peel recalled	Oscor	Packaging Defects	MA

More recalls from Oscor

All 39

Reported	Class	Recall	Company	Reason	Where
22 Jul 2026Device	CLASS I	Abiomed REF: 0052-3006, Introducer Kit for Impella Hemostatic Peel recalled	Oscor	Packaging Defects	MA
22 Jul 2026Device	CLASS I	Abiomed REF: 0052-3021, Introducer Kit for Impella Hemostatic Peel recalled	Oscor	Packaging Defects	MA
23 Feb 2022Device	CLASS II	Destino Twist 14F (also branded as Guidestar 14F) recalled by Oscor	Oscor	Other	PA, TN
7 Apr 2021Device	CLASS II	AngioDynamics SafeSheath Ultralite 10F recalled by Oscor	Oscor	Sterility	Nationwide
14 Nov 2018Device	CLASS I	TB Series Bipolar Pacing Leads, French Size 4F, 5F, 6F recalled by Oscor	Oscor	Device Malfunction	Nationwide

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7 Oct 2026Device	CLASS II	Medical convenience kits containing BD CliniClean Pericare recalled	American Contract Systems	Device Malfunction	Nationwide
7 Oct 2026Device	CLASS II	Medical convenience kits containing BD CliniClean Pericare recalled	American Contract Systems	Device Malfunction	Nationwide
7 Oct 2026Device	CLASS II	Pipeline Flex Embolization Device with Shield Technology recalled	Micro Therapeutics	Labeling Errors	Nationwide
7 Oct 2026Device	CLASS II	System (RED 62 Reperfusion Catheter) recalled by Penumbra	Penumbra	Device Malfunction	Nationwide
7 Oct 2026Device	CLASS II	Medical convenience kits containing BD CliniClean Pericare recalled	American Contract Systems	Device Malfunction	Nationwide