Zoom 4s Catheter
Zoom 4S is an aspiration catheter used with compatible tubing and a vacuum pump to remove thrombus during revascularization for acute ischemic stroke. The system's indication covers…
Zoom 4S is an aspiration catheter used with compatible tubing and a vacuum pump to remove thrombus during revascularization for acute ischemic stroke. The system’s indication covers specified intracranial large-vessel occlusions within eight hours of last known well.
The single-lumen catheter has braid and coil reinforcement, variable stiffness, a distal radiopaque marker and hydrophilic coating. A proximal Luer hub connects to the aspiration pathway, with a rotating hemostasis valve supplied.
Listed Item
Zoom 4S Reperfusion Catheter, 125cm
Access and Selection
The catheter accepts guidewires up to 0.035 inch and requires a guide sheath with at least a 0.071 inch inner diameter. Treatment candidates are ineligible for intravenous thrombolysis or have not responded to it.
Who Else Makes It
Concentrated in Shanghai (3), Jiangsu (2). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Covidien Medical Products (Shanghai) Manufacturing LLC | Shanghai | Shanghai | Contract manufacturer | 8 |
| Sterigenics Shanghai ETO Ltd. | Shanghai | Shanghai | Contract manufacturer | 65 |
| Steris Sterilization Technologies (Suzhou) Ltd | Suzhou | Jiangsu | Contract manufacturer | 44 |
| Suzhou Zenith Vascular Scitech Limited | Suzhou | Jiangsu | Manufacturer | 6 |
| Shanghai Wallaby Medical Technologies Co., Inc. | Shanghai | Shanghai | Contract manufacturer | 5 |
Record
| Listed by | Imperative Care Inc., United States |
|---|---|
| FDA product code | NRY |
| Device type | Catheter, Thrombus Retriever |
| Device class | Class 2 |
| Regulation | 21 CFR 870.1250 |
| Establishment | Specification developer, Complaint-file establishment, Manufacturer |
| 510(k) | K252046 |
| Record published | 2025-11-24 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date |
| Storage | Special storage condition: Keep dry. Keep away from sunlight. Store at room temperature. |
| Sizes | Lumen/inner diameter 0.045 in; outer diameter 0.062 in; catheter length 125 to 160 cm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| ICRC04S125 | Lumen/Inner Diameter 0.045 in | In distribution |
| ICRC04S160 | Lumen/Inner Diameter 0.045 in | In distribution |
| ICRC04S144 | Lumen/Inner Diameter 0.045 in | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Penumbra System | Penumbra Inc. | 100 |
| RED 43 | Penumbra Inc. | 18 |
| Solitaire™ X-Pack | Micro Therapeutics, Inc. | 14 |
| ACE | Penumbra Inc. | 14 |
| Raptor Aspiration Catheter | Balt USA, LLC | 13 |
| Cereglide | Cerenovus, Inc. | 13 |
| Solitaire™ | Micro Therapeutics, Inc. | 9 |
| Solitaire™ X | Micro Therapeutics, Inc. | 9 |
| RED 68 | Penumbra Inc. | 9 |
| Riptide™ | Micro Therapeutics, Inc. | 9 |
| Zoom™ Reperfusion Catheter | Imperative Care Inc. | 9 |
| CaptureTM | Micro Therapeutics, Inc. | 8 |
Showing 12 of 80. All products under Catheter, Thrombus Retriever
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K252046 | 2025-10-30 |
| K243047 | 2025-05-28 |
| K242672 | 2025-01-14 |
| K211476 | 2021-06-08 |
| K210996 | 2021-04-23 |
| K202182 | 2020-09-02 |
| K183043 | 2019-04-17 |
Recalls
1 of these is Class I. Class I is the FDA’s most serious grade: a reasonable probability of serious injury or death. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|
| 2021-08-13 | Class I | Under Investigation by firm | There is a potential for distal end of catheters to fracture and become detached. | 3118 units |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.