Z-2951-2011

Spectranetics Turbo-Booster Laser Guide Catheter, 7 Fr, REF 518-043, Sterile EO, Spectranetics Corporation...

Name: Z-2951-2011 Spectranetics Turbo-Booster Laser Guide Catheter, 7 Fr, REF 518-043, Sterile EO, Spectranetics Corporation...
Creator: Spectranetics Corporation
Published: 2011-07-18
License: https://open.fda.gov/license/

Spectranetics Corp. / initiated 2011-07-18 / Terminated / root cause: packaging

FDA source

Spectranetics Corporation began a recall of Spectranetics Turbo-Booster Laser Guide Catheter, 7 Fr, REF 518-043, Sterile EO, Spectranetics Corporation, 96 Talamine Court, Colorado Springs, CO 80907... on 2011-07-18. The reason FDA records is "Packaging integrity may be compromised, thus sterility can not be assured". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-2951-2011
Status: Terminated
Initiated: 2011-07-18
Posted: 2011-08-04
Terminated: 2011-08-12
Recalling firm: Spectranetics Corp.
Product: Spectranetics Turbo-Booster Laser Guide Catheter, 7 Fr, REF 518-043, Sterile EO, Spectranetics Corporation, 96 Talamine Court, Colorado Springs, CO 80907. Designed for directing and supporting Spectranetics laser catheters for use in the treatment of infrainguinal stenoses and occlusions.
Product code: DQY Catheter, Percutaneous
Reason for recall: Packaging integrity may be compromised, thus sterility can not be assured.
Root cause tag: packaging
FDA root cause: Package design/selection
Action: Spectranetics sent an "PRODUCT RECALL NOTICE: EU SHIPMENTS OF TURBO-BOOSTER LASER GUIDE CATHETERS" letter dated July 15, 2011 to all affected customers. The letter identifies the product, problem, and the actions to be taken by the customers. The letter instructs customers to check their inventory and set aside affected product. Customers are to contact their sales representative for information on how to return the affected product and receive replacement product. Further information is available at +011.49.719.447.2539.
Quantity in commerce: 57 units
Distribution: Foreign Distribution-including the countries of Belgium, Cyprus, Germany, Greece, Italy, Spain, Switzerland, and United Kingdom.
Product codes and lots: Lot Numbers: CTB09K14A, FTB09L25C, FTB09M01A, FTB09M02A, FTB10B10B, FTB10F28A, FTB10G12A.

Product code DQY

K071226Class II8Fr Turbo Booster, Guide Catheter, 7Fr Turbo Booster, Model 518-063, 518-043Spectranetics Corp. / cleared 2007-06-29

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)