Turbo Elite Laser Atherectomy Catheter Model Number / UDI-DI code / Product Description 414-151 / 989930000531 / 1.4 mm

FDA device recall Z-0680-2025 · posted 2024-12-16 · Open, Classified

Recall details

Recalling firm

Spectranetics Corporation

Reason for recall

Due to complaints received for the marker band detaching from the distal tip of the catheter and remaining in the patient as laser catheter was retracted.

Action taken

On 11/25/2024, the firm sent an "URGENT MEDICAL DEVICE CORRECTION" Letter via USPS certified mail to customer informing them that Philips has become aware of a potential safety issue with a limited number of Turbo-Elite Laser Atherectomy Catheters where the marker band has the potential to become detached from the device. Detached marker band are visible under fluoroscopy and should remain on the guidewire. Since a detached marker band requires additional intervention to retrieve, temporary or medically reversible adverse health consequences are possible. The potential clinical harms of a detached marker band are embolization, dissection, or perforation, which are harms listed in the Adverse Event Procedural Complications section of the Instructions for Use. Actions to be taken by Customer: Philips recommends the continued use of the Turbo-Elite Laser Atherectomy Catheter and to follow the Instructions for Use, including using fluoroscopy to ensure the marker band is not left behind after retracting the device. As a precaution, if a marker band detaches and remains on the wire in the patient, then additional intervention to retrieve the marker band is required. There are multiple possible endovascular interventions to retrieve a detached marker band including snaring, balloon catheter inflation, and using a filter wire to capture the marker band. If these techniques are unsuccessful, then stenting can be used to secure the marker band in place to avoid distal embolization. Ensure you report all occurrences of this issue to Philips via a complaint. For questions or assistance-contact local Philips representative or Philips Image Guided Therapy Devices Customer Service at 1-800-231-0978, option 2.

Root cause

Device Design

Status

Open, Classified

Product code

MCW

Quantity affected

40,276 catheters

Distribution

U.S.: AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, ILIN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD TN, TX, UT, VA, WA, WI, and W

Date initiated

2024-11-25

Date posted

2024-12-16

Location

Colorado Springs, CO

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