Recall Z-2403-2021
Micro Therapeutics Inc, · initiated July 13, 2021
Class I – dangerous or defective products that could cause serious health problems or death
Product
EV3 Pipeline Flex Embolization Device with Flex Shield Technology
Codes / lots: Product/REF/UDI: PED2-250-10 PIPELINE FLEX SHIELD PED2-250-10 00847536002029 Lot Numbers: A816342 A827596 A834390 A849720 Product/REF/UDI: PED2-250-14 PIPELINE FLEX SHIELD PED2-250-14 00847536002043 Lot Numbers: A812725 A832008 A833123 A846924 Product/REF/UDI: PED2-250-16 PIPELINE FLEX SHIELD PED2-250-16 00847536002050 Lot Numbers: A816342 A826273 A827599 A832010 A842690 A846927 Product/REF/UDI: PED2-250-20 PIPELINE FLEX SHIELD PED2-250-20 00847536002074 Lot Numbers: A810946 A816343 A816343 A819116 Product/REF/UDI: PED2-275-12 PIPELINE FLEX SHIELD PED2-275-12 00847536002098 Lot Number: A916293 Product/REF/UDI: PED2-275-14 PIPELINE FLEX SHIELD PED2-275-14 00847536002104 Lot Numbers: A830303 A830304 A846930 A846931 Product/REF/UDI: PED2-275-16 PIPELINE FLEX SHIELD PED2-275-16 00847536002111 Lot Numbers: A819135 A846932 A855391 A859750 A869908 A871955 A873194 Product/REF/UDI: PED2-275-18 PIPELINE FLEX SHIELD PED2-275-18 00847536002128 Lot Numbers: A810946 A821512 A836546 A849721 Product/REF/UDI: PED2-275-20 PIPELINE FLEX SHIELD PED2-275-20 00847536002135 Lot Numbers: A827600 A842691 Product/REF/UDI: PED2-300-10 PIPELINE FLEX SHIELD PED2-300-10 00847536002142 Lot Numbers: A833123…
Reason for recall
Due to potential push wire fractures in the delivery system during use. The issue presents as a fracture in the spiral cut area of the Hypotube.
FDA-determined cause: Device Design
Action taken
On 07/13/2021, the firm sent via mail courier service an "URGENT: MEDICAL DEVICE RECALL" Notification letter to customer informing them they have received reports of serious injuries and deaths in connection with delivery pushwire fracture at the distal section of the delivery system during use. This recall affects all models of the embolization devices manufactured between April - October 2019, and April - May 2020. Customers are instructed to: 1. Do NOT use any impacted product. Remove and quarantine all unused impacted products in their inventory. 2. Return the impacted products to the Recalling Firm. Their Recalling Firm representative can assist in facilitating the return of product as necessary. If alternative product is needed, their Recalling Firm representative can assist them with identifying suitable replacement product. 3. Complete the attached Customer Confirmation Form, see Attachment 2, and fax it to 1-651-367-7075 to the attention of Neurovascular Quality or email it to rs.navfca@medtronic.com. 4. Share this communication within their organization, with other organizations where impacted devices may have been transferred, and any other associated organizations that may be impacted by this action. For additional questions and/or assistance, contact the Recalling Firm's Representative or email the Office of Medical Affairs at rs.nvoma@medtronic.com.
Details
- Recall number
- Z-2403-2021
- Initiated
- July 13, 2021
- Product code
- OUT – Intracranial Aneurysm Flow Diverter
- Quantity
- 16,169 total devices for all model/products
- Distribution
- U.S.: 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, Puerto Rico, RI, SC, SD, TN, TX, UT, VA, WA, WI, and WV O.U.S.: Argentina, Brazil Canada, Chile, Colombia, Ecuador, Mexico, Peru, Austria, Belgium, Canary Island, Croatia, Czech Republic, Denmark, Finland, France, Germany, Greece, Hungary…
- Recalling firm
- Micro Therapeutics Inc,, Irvine, CA
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-2402-2021 Class I | Pipeline Flex Embolization DeviceDue to potential push wire fractures in the delivery system during use. The issue presents as a fracture in… | 07/13/2021Open, Classified |