Z-0085-04

Concentric brand Concentric Retriever X5 Percutaneous Catheter Model REF 90035

Name: Z-0085-04 Concentric brand Concentric Retriever X5 Percutaneous Catheter Model REF 90035
Creator: Concentric Medical Inc
Published: 2003-09-24
License: https://open.fda.gov/license/

Concentric Medical, Inc. / initiated 2003-09-24 / Terminated

FDA source

Concentric Medical Inc began a recall of Concentric brand Concentric Retriever X5 Percutaneous Catheter Model REF 90035 on 2003-09-24. The reason FDA records is "The device has the potential for tip breakage during use". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0085-04
Status: Terminated
Initiated: 2003-09-24
Posted: 2004-07-20
Terminated: 2003-12-04
Recalling firm: Concentric Medical, Inc.
Product: Concentric brand Concentric Retriever X5 Percutaneous Catheter Model REF 90035
Product code: DQY Catheter, Percutaneous
Reason for recall: The device has the potential for tip breakage during use.
FDA root cause: Other
Action: On 09/24/03, the firm issued letters and follow-up letters on 10/17/03 via FedEx to all its direct consignees, informing them of the affected devices and providing instructions on the recall.
Quantity in commerce: 97 units
Distribution: 7 consignees in the US were shipped Concentric Retriever X5 or Concentric Retriever X6 devices with lot number 31494 or lower. A total of 97 units affected were released for US distribution. Distribution was limited to 6 States: MA, GA, NY, OH, MO and CA. The recall was appropriately extended to the user level; i.e., the hospitals which received the recalled products. There were no shipments to U.S. Government facilities or foreign or Canadian distribution.
Product codes and lots: Lot numbers: 31494 or lower

Product code DQY

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)