The Recall Desk
HighFDA (Devices)·Z-0158-2022·Announced 2021-10-27

Medtronic surgical blades recalled for tip breaks and vibration

Medtronic recalls 274,991 sterile surgical blades due to complaints of tip breaks and vibration during use. The blades are components of surgical systems used in brain and ENT procedures.

What this means for you

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: This FDA Class II recall involves surgical instrument components where tip breaks and vibration could affect patient safety during use. No patient injuries are reported in the source text, but the potential risk of harm from blade failure during brain and ENT surgery justifies a High severity classification.

Plain-English summary

Medtronic Xomed, Inc. is recalling 274,991 sterile single-use surgical blades used as components in the StraightShot M Series Handpiece, Fusion ENT Navigation Software, Midas Rex Microsaw, and Triton System. These blades have been distributed worldwide.

The recall was initiated due to an increase in complaints related to tip breaks and vibration. The affected products include multiple blade types and sizes with reference numbers from 40A2500 to 45S2500.

Hospitals, surgery centers, and healthcare facilities that use these blades should stop using affected lots immediately. Users should contact Medtronic Xomed for instructions on returning or replacing the recalled products.

For more information, healthcare providers with questions should reach out to Medtronic directly regarding the recall and to arrange replacement of the affected devices.

The recalled product

Product
Medtronic Sterile single-use blades that are components of the StraightShot M Series Handpiece and Fusion ENT Navigation Software, and the Midas Rex Microsaw and Triton System with the following product numbers: (1) REF 40A2500, Nucleus Removal Angled Blade, 25 cm x 4.0 mm; (
Manufacturer
Medtronic Xomed, Inc.
Category
Medical Device — Surgical Blades
Hazard
  • blade-tip-break
  • vibration

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)

  • (1) REF 40A2500
  • GTIN/UPN 00763000033835
  • Lot/serial number 0220002825
  • (2) REF 40R2000
  • GTIN/UPN 00763000033866
  • Lot/serial number 0218179458
  • (3) REF 40R2500
  • GTIN/UPN 00763000033798
  • Lot/serial number 0218299192
  • (4) REF 40S2000
  • GTIN/UPN 00763000033873
  • Lot/serial number 0218179459
  • (5) REF 40S2500
  • GTIN/UPN 00763000043193
  • Lot/serial number 0220226674
  • (6) REF 45A2000
  • GTIN/UPN 00763000033880
  • Lot/serial number 0220443669
  • (7) REF 45A2500
  • GTIN/UPN 00763000043223

Distribution

Distributed nationwide across the United States.

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