Spectranetics Corporation 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 support Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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 support
Brand
Spectranetics Corporation
Lot Codes / Batch Numbers
Lot Number: 080417D.
Products Sold
Lot Number: 080417D.
Spectranetics Corporation is recalling Turbo Elite 0.9mm Turbo Elite (TE) RX, Model #410-154, tip diameter 0.9mm/.038 in, 4 Fr, sterile EO. due to The catheter pouch label was incorrectly labeled with the wrong size.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
The catheter pouch label was incorrectly labeled with the wrong size.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026