Plato 17 Microcatheter REF PL17-160-090 To assist in delivery of therapeutic devices and embolization materials and infusion of diagnostic…
Scientia Vascular, Inc. · Due to manufacturing non-conformance that resulted in channels in the seal on the packaging pouch. As a result, this could potential create a breach in the ste…
Open FDA's page for this record- Cfres ID
- 212251
- Product res number
- Z-1235-2025
- Event date initiated
- 2025-01-16
- Event date posted
- 2025-02-26
- Recall status
- Open, Classified
- Res event number
- 96175
- Product code
- QJP
- Code info
- Catalog Number: PL17-160-090 UDI-DI code: 00818075010479 Lot Number: 031300
- Firm FEI number
- 3009546466
- Recalling firm
- Scientia Vascular, Inc.
- Address 1
- 2460 S 3270 W
- City
- West Valley City
- State
- UT
- Postal code
- 84119-1116
- Additional info contact
- Mr. Larry Myres 760-899-4649
- Root cause description
- Under Investigation by firm
- Product quantity
- 1 unit
- Distribution pattern
- U.S. Nationwide distribution in the state of DE.
- Product description
Plato 17 Microcatheter REF PL17-160-090 To assist in delivery of therapeutic devices and embolization materials and infusion of diagnostic agents to the neuro and peripheral vasculature during interventional or diagnostic procedures.
- Reason for recall
Due to manufacturing non-conformance that resulted in channels in the seal on the packaging pouch. As a result, this could potential create a breach in the sterile barrier.
- Action
On 01/02/2025, the firm email an "URGENT: MEDICAL DEVICE RECALL" Letter to customers informing them that through internal evaluation of finished goods of the Plato 17 Microcatheter, one lot of pouches containing the 90 Tip Plato 17 Microcatheter was identified with pouches that had a gap in the sterile barrier seal. Customer are instructed to: In situations where a device has already been used in a patient procedure, closely monitor patients for signs and symptoms of post-surgical infection. Customer Service will be available to provide additional information and provide replacement orders at customercare@scientiavascular.com or (888)385-9016; Monday through Friday, 8:00 AM to 4:30 PM, Mountain Time.
- K numbers
- K223560
- Harmonized identifiers (openFDA)
- Device name
- Catheter, Percutaneous, Neurovasculature
- Medical specialty description
- Cardiovascular
- Regulation number
- 870.1250
- Device class
- 2
- K number
- K233205, K213589, K211893, K260199, K231802, K202926, K240971, K252297, K221822, K210635, K231056, K241637, K240529, K214048, K201682, K252569, K253032, K242301, K230609, K240711, K212340, K221930, K231583, K261889, K260938, K203842, K260220, K212838, K222743, K240948, K223560, K261176, K243577, K233924, K241768, K261808, K212288, K202752, K203764, K200206 +63 more
- Registration number
- 3013656790, 3017278832, 3015550451, 3015615738, 3012543881, 3025028711, 3008264254, 2030624, 1048735, 3013858269, 3020954126, 3006451981, 3015453963, 3031311812, 3006010712, 3009965866, 3010079067, 3017210488, 3009337401, 3017168767, 3008837339, 3003775027, 2183744, 3019807891, 3013556777, 2029214, 3014766734, 3007007790, 3014211783, 3008824097, 3027319104, 3008881809, 3011370111, 3014779787, 3013944123, 3004063494, 3032047719, 3013758550, 3015701715, 1035166 +36 more
- FEI number
- 3013656790, 3017278832, 3015550451, 3015615738, 3012543881, 3025028711, 3008264254, 1048735, 3013858269, 3020954126, 3006451981, 3015453963, 3031311812, 3006010712, 3009965866, 3010079067, 3017210488, 3009337401, 3017168767, 3008837339, 3003775027, 2183744, 3003495548, 3013556777, 3019807891, 3014766734, 3007007790, 3014211783, 3008824097, 3027319104, 3008881809, 3011370111, 3014779787, 3013944123, 3004063494, 3032047719, 3013758550, 3015701715, 1035166, 1047843 +36 more