Z-0916-03

10.5 Fr. Percor STAT-DL intra-Aortic Balloon Catheter Insertion Kits which contain a Datascope 11.5 Fr. 11''...

Name: Z-0916-03 10.5 Fr. Percor STAT-DL intra-Aortic Balloon Catheter Insertion Kits which contain a Datascope 11.5 Fr. 11''...
Creator: Datascope Corp
Published: 2003-03-21
License: https://open.fda.gov/license/

Datascope Corp. / initiated 2003-03-21 / Terminated

FDA source

Datascope Corp began a recall of 10.5 Fr. Percor STAT-DL intra-Aortic Balloon Catheter Insertion Kits which contain a Datascope 11.5 Fr. 11'' introducer sheaths. These introducer sheaths... on 2003-03-21. The reason FDA records is "10.5 Fr. Percor STAT-DL Intra-Aortic Balloon Insertion Kit, Introducer Sheath failed water leak test during final inspection". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0916-03
Status: Terminated
Initiated: 2003-03-21
Posted: 2003-06-05
Terminated: 2003-08-01
Recalling firm: Datascope Corp.
Product: 10.5 Fr. Percor STAT-DL intra-Aortic Balloon Catheter Insertion Kits which contain a Datascope 11.5 Fr. 11'' introducer sheaths. These introducer sheaths include a hemostasis valve and a hub which work in conjunction with an introducer dilator. The introducer sheath, after it is dilated by the introducer dilator, is intended to assist the percutaneous insertion of the 10.5 Fr. Intra-Aortic Balloon catheter into the vasculature.
Product code: DSP System, Balloon, Intra-Aortic And Control
Reason for recall: 10.5 Fr. Percor STAT-DL Intra-Aortic Balloon Insertion Kit, Introducer Sheath failed water leak test during final inspection.
FDA root cause: Other
Action: Recall letters were sent via US mail return receipt requested to customers on 3/31/2003. Sales representatives received a letter on 3/28/2003.
Quantity in commerce: 60 units
Distribution: Product was distributed domestically to hospitals nationwide. There are no US government or foreign consignees.
Product codes and lots: REF or Order #0684-00-0195-02; P/N #0684-00-0438; Lot #BRV; Exp. Date 03/03/05.

Product code DSP

K964987Class IIDatascope Percor Stat - Dl 9.5 Fr. 25 and 40Cc Intra-Aortic Balloon for Optional Sheathless Insertion and Percor Stat -0Datascope Corp. / cleared 1997-03-17

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)