RecallRadar

FDA Device recall Z-1732-2020

Sensor Nitinol Wire with Hydrophilic Tip .0383CM FLEX ANG/150CM UPN: M0066703101 box 5 UPN: M0066703100 single unit

On 2020-04-29 the FDA classified a Class II recall of Sensor Nitinol Wire with Hydrophilic Tip .0383CM FLEX ANG/150CM UPN: M0066703101 box 5 UPN: M0066703100 single unit by Boston Scientific, citing an increase in the rate of complaints for difficulty or inability to track over the guidewire, may result in a procedural delay due to the need to exchange the affected device.

Read the official FDA Device notice

AgencyFDA Device
Recall numberZ-1732-2020
ClassificationClass II
Statusongoing
Initiated2020-03-09
Published2020-04-29
Last updated2026-09-13 11:55 UTC
CompanyBoston Scientific
DistributionUS

Product

Sensor Nitinol Wire with Hydrophilic Tip .0383CM FLEX ANG/150CM UPN: M0066703101 box 5 UPN: M0066703100 single unit

Reason

An increase in the rate of complaints for difficulty or inability to track over the guidewire, may result in a procedural delay due to the need to exchange the affected device

Identifiers

code_infoLot Numbers: 24538844, 24647121

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: ongoing.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1732-2020%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.