MAUDE Adverse Event Report: ABIOMED, INC. - 1220648 IMPELLA; TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP

Catalog Number	0048-0024-JP
Medical Device Problem Codes	Device Damaged by Another Device (2915); Device Sensing Problem (2917)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/14/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A3 and a4 are unknown.This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by abiomed inc or its employees that the report constitutes an admission that the product, abiomed inc, or its employees, caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
Event or Problem Description
It was reported that a patient implanted with an impella cp experienced a placement signal not reliable alarm.The alarm was disabled and no patient harm was reported.
Additional Manufacturer Narrative
D6b, date of explant, has been added.
Additional Manufacturer Narrative
The impella device was returned, and an evaluation is underway.Upon completion of our analysis, a supplemental report will be filed.Section d9 has been updated.Section d1 brand name corrected.
Additional Manufacturer Narrative
H6 updated with a0502.The investigation is still ongoing.
Additional Manufacturer Narrative
Corrected information has been provided in h9.
Additional Manufacturer Narrative
Added d3 manufacturer fax was omitted during initial report.Corrected d4 serial number.Updated h3 device evaluated by manufacturer to "yes".H6 investigation: type, findings, and conclusion codes and h6 component codes were updated accordingly based on the completed investigation.The cause of the placement signal issue was optical sensor damage.Per the impella cp ifu (0048-9007): "use with shockwave intravascular lithotripsy (ivl) catheter at a distance of less than 20 mm between the optical sensor and ivl device may interfere with or damage the impella optical sensor." though an image was returned measuring the two devices at 25.22 mm apart, the measurement could not be confirmed to be correct/accurate based on several potential errors in the methods.For this reason, the cause of the optical sensor damage could not be established.

• Brand Name: IMPELLA
• Common Device Name: TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP
• Manufacturer (Section D): ABIOMED, INC. - 1220648; 22 cherry hill drive; danvers MA 01923
• Manufacturer Contact: derek sammarco ; 22 cherry hill drive; danvers, MA 01923 ; 7814934967
• MDR Report Key: 24615851
• Report Number: 1220648-2026-05409
• Device Sequence Number: 9575325
• Product Code: OZD
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: P140003
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Device Explanted Year: 2026
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 04/10/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 0048-0024-JP
• Device Lot Number: 2026737792
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/15/2026
• Supplement Date Received by Manufacturer: 03/17/2026; 04/06/2026; 04/09/2026; 06/12/2026; 06/16/2026
• Initial Report FDA Received Date: 03/17/2026
• Supplement Report FDA Received Date: 03/18/2026; 04/08/2026; 04/11/2026; 06/15/2026; 06/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/18/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: 95129
• Patient Sequence Number: 1
• Patient Age: 74 YR
• Patient Sex: Unknown
• Patient Race: Asian