The Recall Desk
SevereFDA (Devices)·Z-2403-2021·Announced 2021-09-15

EV3 Pipeline Flex Embolization Device Recalled for Push Wire Fracture Risk

Micro Therapeutics Inc. is recalling 16,169 EV3 Pipeline Flex Embolization Devices due to potential push wire fractures in the delivery system during use.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The FDA classified this recall as Class I, which per FDA guidance indicates serious hazard potential and never goes below severity score 4. The identified push wire fracture risk in a critical delivery system component could compromise device function during use, though no illnesses or injuries have yet been reported.

Plain-English summary

Micro Therapeutics Inc. is recalling 16,169 EV3 Pipeline Flex Embolization Devices with Flex Shield Technology, distributed throughout the United States and internationally.

The recall is due to potential push wire fractures that may occur in the delivery system during use. These fractures develop in the spiral cut area of the Hypotube, a critical component of the device's delivery mechanism.

The FDA has classified this as a Class I recall, indicating serious hazard potential. No illnesses or injuries have been reported to date.

The recalled product

Product
EV3 Pipeline Flex Embolization Device with Flex Shield Technology
Manufacturer
Micro Therapeutics Inc,
Category
Medical Device — Interventional Neurovascular Device
Hazard
  • push-wire-fracture
  • device-failure

Distribution

Distributed in 48 states:

  • AK
  • AL
  • AR
  • AZ
  • CA
  • CO
  • CT
  • DC
  • DE
  • FL
  • GA
  • HI
  • IA
  • ID
  • IL
  • IN
  • KS
  • KY
  • LA
  • MA
  • MD
  • ME
  • MI
  • MN
  • MO
  • MS
  • NC
  • ND
  • NE
  • NH
  • NJ
  • NM
  • NV
  • NY
  • OH
  • OK
  • OR
  • PA
  • RI
  • SC
  • SD
  • TN
  • TX
  • UT
  • VA
  • WA
  • WI
  • WV

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