Home › BALT USA LLC › Balt Aspiration Tubing Set
Balt Aspiration Tubing Set
BALT USA LLC · Model BASPT-110 · UDI-DI 00810068563986
NRY
Prescription
10
510(k) clearances
8,663
Adverse events (901 deaths)
26
Recalls
59
Facilities
Description
The Balt Aspiration Tubing Set is intended to connect the Raptor Aspiration Catheter to the canister of a compatible aspiration pump and to allow the user to control the fluid flow.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-06-03 | Penumbra, Inc. | Due to manufacturing issues, reperfusion catheters may fractures |
| 2025-02-26 | Qapel Medical Inc. | Aspiration catheter distal tip features and characteristics may not be in the scope of FDA clearance; tip detachment, vessel rupture, and vasospasm could occur. |
| 2025-01-02 | 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 sterile barrier. |
| 2024-08-05 | MICROVENTION INC. | Due to Retrieval Device product labels stating the incorrect expiration dates that (5 years instead of 3 years) which extends beyond their true expiration date. |
| 2024-04-23 | Stryker Neurovascular | Neurovascular devices did not meet the minimum sample size required for endotoxin testing during manufacturing processes and are out of compliance with the AAMI ST72 standard, so t |
| 2024-03-08 | ROUTE 92 MEDICAL INC | Their is the potential for distal tip separation at the proximal marker band of the delivery catheters |
| 2021-08-13 | IMPERATIVE CARE INC | There is a potential for distal end of catheters to fracture and become detached. |
| 2020-12-15 | Penumbra Inc. | The catheter may become susceptible to distal tip damage during use. Distal tip damage in conjunction with pressurization of contrast injection may result in potential vessel dama |
| 2020-12-15 | Penumbra Inc. | The catheter may become susceptible to distal tip damage during use. Distal tip damage in conjunction with pressurization of contrast injection may result in potential vessel dama |
| 2020-12-15 | Penumbra Inc. | The catheter may become susceptible to distal tip damage during use. Distal tip damage in conjunction with pressurization of contrast injection may result in potential vessel dama |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.