The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-2230-2023·Announced 2023-08-02

Laser Fiber Devices May Overheat and Cause Burns During Use

Boston Scientific is recalling Flexiva Pulse 242 laser fibers due to manufacturing defects that may cause the fiber connector to overheat and cause burn injuries. The recall affects 1,245 units distributed in the US and Canada.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: FDA Class II recall with no reported illnesses or injuries. The hazard is a potential burn injury from overheating fiber connector if touched during use, which is a risk-of-harm scenario that has not yet been realized.

Plain-English summary

Boston Scientific Corporation is recalling Flexiva Pulse 242 TracTip Single-Use Laser Fibers (5-pack, UPN M006L8405961), medical devices used to transmit Ho:YAG laser energy from cleared laser consoles to the urinary tract during surgical procedures. The recall affects 1,245 units distributed in the United States and Canada.

Units were manufactured with an incorrect component that results in lower power output and degradation or dimming of the aiming beam, reducing fiber performance efficiency. Continued use of affected devices may cause the fiber connector to overheat, which could result in a burn injury if the connector is touched.

The recalled product

Product
Flexiva Pulse 242 TracTip Single-Use Laser Fibers -intended to be used as a device that transmits Ho:YAG laser energy from cleared laser consoles to urological anatomy. 5-pack UPN: M006L8405961
Manufacturer
Boston Scientific Corporation
Category
Medical Device — Surgical / Laser Equipment
Hazard
Affected units
1,245

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

  • GTIN: 08714729978664 Lot Numbers: 2030305543
  • 30305544
  • 30305545
  • 30305546
  • 30305547
  • 30305548
  • 30305549
  • 30389370
  • 30389371
  • 30389372
  • 30389373
  • 30389375
  • 30389376
  • 30389377
  • 30389378
  • 30429835
  • 30429837
  • 30479586
  • 30479587
  • 30479589

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 7 recalled by Boston Scientific Corporation under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 7 products in this recall →

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