The Recall Desk
Agency classClass IIOur severity:SevereFDA (Devices)·Z-2161-2015·Announced 2015-07-29

FDA Recalls Sureflex 910 Lithotripsy Fibers Due to Cleaning Validation Issues

American Medical Systems is recalling 16,710 Sureflex 910 Lithotripsy Fibers because cleaning and sterilization validation data do not meet FDA guidance for reusable products.

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' severity score under the rubric. The hazard involves potential failure of sterilization validation for a surgical device, posing a significant risk of infection or injury.

Plain-English summary

The U.S. Food and Drug Administration (FDA) has issued a Class II recall for the Sureflex 910 Lithotripsy Fiber, 5x, Blue (Model R-LLF910). The recall involves 16,710 units manufactured between April 8, 2012, and April 8, 2015. These laser fibers are intended for use in various surgical procedures, including endoscopic, laparoscopic, and open surgeries involving tissue 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 FDA's new guidance on qualifying reusable products. This discrepancy raises concerns about the ability to properly clean and sterilize the devices, which could potentially impact patient safety during surgical use.

The affected devices were distributed worldwide, including in the United States and numerous other countries such as Argentina, France, Germany, and the United Kingdom. Healthcare facilities and distributors should stop using the affected devices and contact American Medical Systems Innovation Center - Silicon Valley for further instructions on return or replacement.

The recalled product

Product
Sureflex 910 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 Laser Fiber
Hazard

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-LLF910 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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