Z-0976-2009

Turbo Elite 0.9mm Turbo Elite (TE) RX, Model #410-154, tip diameter 0.9mm/.038 in, 4 Fr, sterile EO...

Name: Z-0976-2009 Turbo Elite 0.9mm Turbo Elite (TE) RX, Model #410-154, tip diameter 0.9mm/.038 in, 4 Fr, sterile EO...
Creator: Spectranetics Corporation
Published: 2008-07-04
License: https://open.fda.gov/license/

Spectranetics Corp. / initiated 2008-07-04 / Terminated / root cause: labeling and UDI

FDA source

Spectranetics Corporation began a recall of Turbo Elite 0.9mm Turbo Elite (TE) RX, Model #410-154, tip diameter 0.9mm/.038 in, 4 Fr, sterile EO. Manufactured by Spectranetics, 96 Talamine Court, Colorado... on 2008-07-04. The reason FDA records is "The catheter pouch label was incorrectly labeled with the wrong size". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0976-2009
Status: Terminated
Initiated: 2008-07-04
Posted: 2009-02-11
Terminated: 2009-02-13
Recalling firm: Spectranetics Corp.
Product: Turbo Elite 0.9mm Turbo Elite (TE) RX, Model #410-154, tip diameter 0.9mm/.038 in, 4 Fr, sterile EO. Manufactured by Spectranetics, 96 Talamine Court, Colorado Springs, CO 80907. The pouch label of the 1.4mm TE Over the Wire (OTW) catheter, Ref # 414-151, L/N# 080417D was incorrectly labeled for size as 0.9mm TE RX, Ref# 410-154, L/N#080417D. The box labels are correct and match the devices in the pouch. The Spectranetics TURBO-BoosterTM guiding catheter is designed for directing and supporting Spectranetics laser catheters for use in the treatment of infrainguinal stenoses and occlusions.
Product code: MJQ
Reason for recall: The catheter pouch label was incorrectly labeled with the wrong size.
Root cause tag: labeling and UDI
FDA root cause: Error in labeling
Action: The mislabeled catheter was returned to Spectranetics. The second possible mislabeled catheter was visually inspected by a Spectranetics representative and confirmed the catheter was labeled correctly.
Quantity in commerce: 2 units
Distribution: Nationwide Distribution including states of TX and FL.
Product codes and lots: Lot Number: 080417D.

Product code MJQ

K071227Class IIClirpath Turbo Excimer Laser Catheter (Rx) -0.9Mm, (Rx) -1.4Mm, (Rx) -1.7Mm, (Rx) -2.0Mm, Model 310-154, 314-159, 317-15Spectranetics Corp. / cleared 2007-07-11

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)