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Recall Observatory FDA recall evidence

Device product

Sensor Nitinol Wire with Hydrophilic Tip .038 3CM FLEX STR/150CM UPN: M006670309 1box 5 UPN: M0066703090 single unit

Z-1731-2020

March 09, 2020

Class II

Product summary

Firm
Boston Scientific
Event
Event 85227
Status
Ongoing
Classification
Class II
Quantity
5,565
Official record key
device-enforcement:Z-1731-2020

Official wording

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

Code information: Lot Numbers: 24501748, 24506585, 24507390, 24507747, 24517205, 24517209, 24517211, 24526341, 24576484, 24576569, 24577900, 24579133, 24580102, 24583255, 24585905, 24586401, 24616721, 24617337, 24618334, 24724936, 24732742, 24737184, 24739802, 24790717, 24805720, 24860825, 24868932

Distribution pattern: Nationwide Foreign: Europe, Middle East and Africa, the Americas (North America and South America, Asia Pacific and Japan

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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