FDA Medical Device Recalls·· 原文未提供具体时分精选AI 评分68
FDA二级召回波士顿科学Direxion微导管：合并41条型号记录
Direxion Torqueable Microcatheter, NGMC/SINGLE/021/BERN/1RO/130; Material Number: M001195240
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FDA召回事件99906涉及Boston Scientific Cork的Direxion Torqueable Microcatheter多个型号。已逐条核对官方事件编号和召回企业；各型号、独立召回编号及FDA原文链接在下方逐项保留。
同一召回 · 41 条型号记录
FDA召回事件编号：99906
| 产品 / 型号 | 召回编号 | 官方原文 |
|---|---|---|
| Direxion Torqueable Microcatheter, NGMC/SINGLE/021/STRAIGHT/1RO/105; Material Number: M001195200 | Z-0223-2027 | 查看原文 |
| Direxion Torqueable Microcatheter, NGMC/SINGLE/021/STRAIGHT/1RO/130; Material Number: M001195210 | Z-0224-2027 | 查看原文 |
| Direxion Torqueable Microcatheter, NGMC/SINGLE/021/STRAIGHT/1RO/155; Material Number: M001195220 | Z-0225-2027 | 查看原文 |
| Direxion Torqueable Microcatheter, NGMC/SINGLE/021/BERN/1RO/105; Material Number: M001195230 | Z-0226-2027 | 查看原文 |
| Direxion Torqueable Microcatheter, NGMC/SINGLE/021/BERN/1RO/130; Material Number: M001195240 | Z-0227-2027 | 查看原文 |
| Direxion Torqueable Microcatheter, NGMC/SINGLE/021/BERN/1RO/155; Material Number: M001195250 | Z-0228-2027 | 查看原文 |
| Direxion Torqueable Microcatheter, NGMC/SINGLE/021/J/1RO/105; Material Number: M001195260 | Z-0229-2027 | 查看原文 |
| Direxion Torqueable Microcatheter, NGMC/SINGLE/021/J/1RO/130; Material Number: M001195270 | Z-0230-2027 | 查看原文 |
| Direxion Torqueable Microcatheter, NGMC/SINGLE/021/J/1RO/155; Material Number: M001195280 | Z-0231-2027 | 查看原文 |
| Direxion Torqueable Microcatheter, NGMC/SINGLE/021/SWAN/1RO/105; Material Number: M001195290 | Z-0232-2027 | 查看原文 |
| Direxion Torqueable Microcatheter, NGMC/SINGLE/021/SWAN/1RO/130; Material Number: M001195300 | Z-0233-2027 | 查看原文 |
| Direxion Torqueable Microcatheter, NGMC/SINGLE/021/SWAN/1RO/155; Material Number: M001195310 | Z-0234-2027 | 查看原文 |
| Direxion Torqueable Microcatheter, NGMC/SINGLE/021/STRAIGHT/2RO/130; Material Number: M001195320 | Z-0235-2027 | 查看原文 |
| Direxion Torqueable Microcatheter, NGMC/SINGLE/021/STRAIGHT/2RO/155; Material Number: M001195330 | Z-0236-2027 | 查看原文 |
| Direxion Torqueable Microcatheter, NGMC/SINGLE/021/BERN/2RO/130; Material Number: M001195340 | Z-0237-2027 | 查看原文 |
| Direxion Torqueable Microcatheter, NGMC/SINGLE/021/BERN/2RO/155; Material Number: M001195350 | Z-0238-2027 | 查看原文 |
| Direxion Torqueable Microcatheter, NGMC/SINGLE/027/STRAIGHT/1RO/105; Material Number: M001195400 | Z-0239-2027 | 查看原文 |
| Direxion Torqueable Microcatheter, NGMC/SINGLE/027/STRAIGHT/1RO/130; Material Number: M001195410 | Z-0240-2027 | 查看原文 |
| Direxion Torqueable Microcatheter, NGMC/SINGLE/027/STRAIGHT/1RO/155; Material Number: M001195420 | Z-0241-2027 | 查看原文 |
| Direxion Torqueable Microcatheter, NGMC/SINGLE/027/BERN/1RO/105; Material Number: M001195430 | Z-0242-2027 | 查看原文 |
| Direxion Torqueable Microcatheter, NGMC/SINGLE/027/BERN/1RO/130; Material Number: M001195440 | Z-0243-2027 | 查看原文 |
| Direxion Torqueable Microcatheter, NGMC/SINGLE/027/BERN/1RO/155; Material Number: M001195450 | Z-0244-2027 | 查看原文 |
| Direxion Torqueable Microcatheter, NGMC/SINGLE/027/J/1RO/130; Material Number: M001195470 | Z-0245-2027 | 查看原文 |
| Direxion Torqueable Microcatheter, NGMC/SINGLE/027/J/1RO/155; Material Number: M001195480 | Z-0246-2027 | 查看原文 |
| Direxion Torqueable Microcatheter, NGMC/SINGLE/027/SWAN/1RO/130; Material Number: M001195500 | Z-0247-2027 | 查看原文 |
| Direxion Torqueable Microcatheter, NGMC/SINGLE/027/SWAN/1RO/155; Material Number: M001195510 | Z-0248-2027 | 查看原文 |
| Direxion Torqueable Microcatheter, NGMC/FATHOM/021/STRAIGHT/1RO/130; Material Number: M001195610 | Z-0249-2027 | 查看原文 |
| Direxion Torqueable Microcatheter, NGMC/FATHOM/021/STRAIGHT/1RO/155; Material Number: M001195620 | Z-0250-2027 | 查看原文 |
| Direxion Torqueable Microcatheter, NGMC/FATHOM/021/BERN/1RO/130; Material Number: M001195640 | Z-0251-2027 | 查看原文 |
| Direxion Torqueable Microcatheter, NGMC/FATHOM/021/BERN/1RO/155; Material Number: M001195650 | Z-0252-2027 | 查看原文 |
| Direxion Torqueable Microcatheter, NGMC/FATHOM/021/STRAIGHT/2RO/130; Material Number: M001195660 | Z-0253-2027 | 查看原文 |
| Direxion Torqueable Microcatheter, NGMC/FATHOM/021/BERN/2RO/130; Material Number: M001195670 | Z-0254-2027 | 查看原文 |
| Direxion Torqueable Microcatheter, NGMC/FATHOM/027/STRAIGHT/1RO/130; Material Number: M001195710 | Z-0255-2027 | 查看原文 |
| Direxion Torqueable Microcatheter, NGMC/FATHOM/027/STRAIGHT/1RO/155; Material Number: M001195720 | Z-0256-2027 | 查看原文 |
| Direxion Torqueable Microcatheter, NGMC/FATHOM/027/BERN/1RO/130; Material Number: M001195740 | Z-0257-2027 | 查看原文 |
| Direxion Torqueable Microcatheter, NGMC/FATHOM/027/BERN/1RO/155; Material Number: M001195750 | Z-0258-2027 | 查看原文 |
| Direxion Torqueable Microcatheter, NGMC/TRANSEND/021/STRAIGHT/1RO/130; Material Number: M001195810 | Z-0259-2027 | 查看原文 |
| Direxion Torqueable Microcatheter, NGMC/TRANSEND/021/BERN/1RO/130; Material Number: M001195840 | Z-0260-2027 | 查看原文 |
| Direxion Torqueable Microcatheter, NGMC/TRANSEND/021/BERN/1RO/155; Material Number: M001195850 | Z-0261-2027 | 查看原文 |
| Direxion Torqueable Microcatheter, NGMC/TRANSEND/027/STRAIGHT/1RO/130; Material Number: M001195910 | Z-0262-2027 | 查看原文 |
| Direxion Torqueable Microcatheter, NGMC/TRANSEND/027/BERN/1RO/130; Material Number: M001195940 | Z-0263-2027 | 查看原文 |
推荐理由
涉及中国在内的多国分销，在华注册与质量负责人需核对批次影响范围。
来源：FDA Medical Device Recalls · accessdata.fda.gov