Z-2682-2026Class I

ABIOMED Impella CP Set, Pump Set Code 0048-0003, containing BIOMED Impella Introducer, 14 Fr, 13 cm & 25 cm...

Name: Z-2682-2026 ABIOMED Impella CP Set, Pump Set Code 0048-0003, containing BIOMED Impella Introducer, 14 Fr, 13 cm & 25 cm...
Creator: Abiomed, Inc.
Published: 2026-06-11
License: https://open.fda.gov/license/

Abiomed, Inc. / initiated 2026-06-11 / Open, Classified / root cause: manufacturing process

FDA source

Abiomed, Inc. began a recall of ABIOMED Impella CP Set, Pump Set Code 0048-0003, containing BIOMED Impella Introducer, 14 Fr, 13 cm & 25 cm, Product Code 0052-3046. heart pump and accessories on 2026-06-11. FDA classified it as Class I and gives the reason as "A potential for introducer sheath leakage from under the sheath cap and along the hub score lines, identified in 14Fr and 23Fr Introducers. These manufacturing issues are not visually detectable by the user, and 14Fr or...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2682-2026
Classification: Class I
Status: Open, Classified
Initiated: 2026-06-11
Posted: 2026-07-10
Recalling firm: Abiomed, Inc.
Product: ABIOMED Impella CP Set, Pump Set Code 0048-0003, containing BIOMED Impella Introducer, 14 Fr, 13 cm & 25 cm, Product Code 0052-3046. heart pump and accessories
Product code: DYB Introducer, Catheter
Reason for recall: A potential for introducer sheath leakage from under the sheath cap and along the hub score lines, identified in 14Fr and 23Fr Introducers. These manufacturing issues are not visually detectable by the user, and 14Fr or 23Fr Introducers are provided in every pump set.
Root cause tag: manufacturing process
FDA root cause: Under Investigation by firm
Action: An URGENT MEDICAL DEVICE RECALL (CORRECTION) notice dated 06/10/2026 was mailed to consignees. The notice directs consignees to maintain awareness of this recall among practitioners and use appropriate clinical awareness, monitoring, and patient support as needed. Further clinical direction is provided in the notice. The notification is to be forwarded to users and to facilities where product was further distributed. The notice should be visible for awareness. Consignees with any questions can contact [email protected].
Quantity in commerce: 87,277 units
Distribution: Worldwide distribution. US Nationwide, Australia (AU), Austria (AT), Belgium (BE), Brazil (BR), Brunei (BN), Canada (CA), China (CN), Croatia (HR), Czech Republic (CZ), Denmark (DK), Finland (FI), France (FR), Germany (DE), Greece (GR), Hong Kong (HK), Ireland (IE), Israel (IL), Italy (IT), Japan (JP), Kuwait (KW), Luxembourg (LU), Malaysia (MY), Mexico (MX), Netherlands (NL), Norway (NO), Panama (PA), Poland (PL), Saudi Arabia (SA), Serbia (RS), Slovenia (SI), South Korea (KR), Spain (ES), Sweden (SE), Switzerland (CH), Taiwan (TW), Thailand (TH), United Arab Emirates (AE), and United Kingdom (GB).
Product codes and lots: Pump Set Code 0048-0003; Introducer Product Code 0052-3046. GTIN: 00813502012279, 00813502011876. All current batches in field.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2682-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2681-2026	Class I	Ongoing	Voluntary: Firm initiated	2026-07-22	2026-07-10
Z-2682-2026	Class I	Ongoing	Voluntary: Firm initiated	2026-07-22	2026-07-10
Z-2683-2026	Class I	Ongoing	Voluntary: Firm initiated	2026-07-22	2026-07-10
Z-2684-2026	Class I	Ongoing	Voluntary: Firm initiated	2026-07-22	2026-07-10
Z-2685-2026	Class I	Ongoing	Voluntary: Firm initiated	2026-07-22	2026-07-10
Z-2686-2026	Class I	Ongoing	Voluntary: Firm initiated	2026-07-22	2026-07-10
Z-2687-2026	Class I	Ongoing	Voluntary: Firm initiated	2026-07-22	2026-07-10
Z-2688-2026	Class I	Ongoing	Voluntary: Firm initiated	2026-07-22	2026-07-10
Z-2689-2026	Class I	Ongoing	Voluntary: Firm initiated	2026-07-22	2026-07-10
Z-2690-2026	Class I	Ongoing	Voluntary: Firm initiated	2026-07-22	2026-07-10
Z-2691-2026	Class I	Ongoing	Voluntary: Firm initiated	2026-07-22	2026-07-10
Z-2692-2026	Class I	Ongoing	Voluntary: Firm initiated	2026-07-22	2026-07-10
Z-2693-2026	Class I	Ongoing	Voluntary: Firm initiated	2026-07-22	2026-07-10

Product code DYB

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)