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Terminated

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.

FDA Recall Z-0916-03 · Posted 2003-06-05

Recalling FirmDatascope Corp
Recall StatusTerminated
Product CodeDSP
Date Initiated2003-03-21
Date Terminated2003-08-01
Product Quantity60 units

Reason for Recall

10.5 Fr. Percor STAT-DL Intra-Aortic Balloon Insertion Kit, Introducer Sheath failed water leak test during final inspection.

Firm 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.

Root Cause

Other

Distribution Pattern

Product was distributed domestically to hospitals nationwide. There are no US government or foreign consignees.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K964987DATASCOPE PERCOR STAT - DL 9.5 FR. 25 AND 40CC INTRA-AORTIC BALLOON FOR OPTIONAL SHEATHLESS INSERTION AND PERCOR STAT -0Datascope Corp. · 1997-03-17

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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