Socrates 38 Aspiration Catheter 127 cm length REF SC038-127-001 The Socrates Aspiration System with a compatible suction pump is intended f…
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
- 212167
- Product res number
- Z-1234-2025
- Event date initiated
- 2025-01-02
- Event date posted
- 2025-02-26
- Recall status
- Open, Classified
- Res event number
- 96158
- Product code
- NRY
- Code info
- Catalog Number: SC038-127-001 UDI-DI code: 00818075011025 Lot Numbers: 030471 030317 030345 030376 030427 030451
- 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
- 120 devices
- Distribution pattern
- U..S. Nationwide distribution in the states of AL, AZ, FL, GA, HI, IL, IN, KS, MN, NC, NJ, NY, PA, SD, TX, VA, WI and WV.
- Product description
Socrates 38 Aspiration Catheter 127 cm length REF SC038-127-001 The Socrates Aspiration System with a compatible suction pump is intended for use in the revascularization of patients with acute ischemic stroke
- 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 initially notified customer via email an "URGENT: MEDICAL DEVICE RECALL" Letter informing them that through internal evaluation of finished goods of the Socrates 38 Aspiration Catheter, one lot of pouches containing the 127 cm Socrates 38 Aspiration Catheter was identified with pouches that had a gap in the sterile barrier seal. This was a result of the pouch not being centered with the sealing bar during the sealing process. On 01/10/2025, The firm sent an updated letter informing customers of additional product lots were added to the Recall. Customers are instructed to: Segregate Recalled Product. Immediately remove all impacted (see list above) Socrates 38 Catheter(s) from their inventory (regardless of its location) and segregate this product in a secure location for return to Scientia Vascular, Inc. 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
- K223913
- Harmonized identifiers (openFDA)
- Device name
- Catheter, Thrombus Retriever
- Medical specialty description
- Cardiovascular
- Regulation number
- 870.1250
- Device class
- 2
- K number
- K260002, K221934, K120961, K243948, K211697, K173200, K251828, K181354, K190212, K190464, K223913, K160641, K183185, K093610, K161064, K173761, K260617, K233329, K141516, K133464, K071172, K113455, K243287, K262398, K142458, K090752, K182522, K222786, K241221, K062046, K141491, K251357, K253590, K061059, K190338, K100769, K261089, K133317, K173452, K242672 +77 more
- Registration number
- 3013656790, 3015550451, 3015615738, 3016678045, 3022392708, 3012543881, 3008264254, 3014498720, 2030624, 1048735, 3020954126, 3006451981, 3015453963, 3017168767, 3010079067, 3009337401, 2183828, 3008837339, 2183744, 3019807891, 3013556777, 2029214, 3007007790, 3014211783, 3008824097, 3027319104, 3008881809, 3011370111, 1721504, 3014590707, 3013758550, 3015701715, 3021520400, 3009957947, 3009546466, 3015531723, 2024311, 3008114965, 3016591327, 3031288142 +21 more
- FEI number
- 3013656790, 3015550451, 3015615738, 3016678045, 3022392708, 3012543881, 3008264254, 3014498720, 1048735, 3020954126, 3006451981, 3015453963, 3017168767, 3010079067, 3009337401, 2183828, 3008837339, 2183744, 3019807891, 3013556777, 3007007790, 3014211783, 3008824097, 3027319104, 3008881809, 3011370111, 1721504, 3014590707, 3013758550, 3015701715, 3009024869, 3021520400, 3009957947, 3009546466, 3015531723, 2024311, 3008114965, 3016591327, 3004099094, 3014590708 +21 more