The Recall Desk
Agency classClass IIOur severity:SevereFDA (Devices)·Z-2156-2015·Announced 2015-07-29

FDA Recalls Sureflex 150 Lithotripsy Fibers Due to Sterilization Validation Issues

American Medical Systems is recalling Sureflex 150 Lithotripsy Fibers because cleaning and sterilization validation data do not meet FDA guidance for reusable medical devices.

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 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The recall is classified as FDA Class II, which corresponds to a 'Severe' rating under the rubric. The hazard involves a failure in sterilization validation for a reusable surgical device, posing a significant risk of infection or injury if the device is used without proper processing.

Plain-English summary

The U.S. Food and Drug Administration (FDA) has issued a Class II recall for the Sureflex 150 Lithotripsy Fiber, 5x, Blue, manufactured by American Medical Systems Innovation Center - Silicon Valley. The recall affects approximately 13,710 units of the device, which are intended for use in laser-based surgical applications involving the vaporization, ablation, and fragmentation of calculi.

The recall was initiated because validation data related to cleaning instructions and sterilization methods for the Sureflex Reusable Fibers and associated accessories do not meet the new FDA guidance on qualifying reusable products. This deficiency raises concerns about the ability to properly clean and sterilize the devices, which could potentially lead to patient harm if the devices are not adequately processed between uses.

The affected devices were distributed worldwide, including in the United States and numerous international markets. Healthcare facilities and distributors should stop using the affected Sureflex 150 Lithotripsy Fibers immediately and contact American Medical Systems for instructions on how to return the devices for replacement or refund.

The recalled product

Product
Sureflex 150 Lithotripsy Fiber, 5x, Blue; Sure F!ex laser fibers are intended for use in laser-based surgical applications, including, but not limited to endoscopic, laparoscopic and open surgical procedures involving vaporization, ablation, coagulation, hemostasis, excision…
Manufacturer
American Medical Systems Innovation Center - Silicon Valley
Category
Medical Device — Surgical Instruments
Hazard
Affected units
13,710

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 (3)

  • Model R-LLF150TG: All product manufactured from April 8
  • 2012 to April 8
  • 2015

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 32 recalled by American Medical Systems Innovation Center - Silicon Valley 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 32 products in this recall →

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