FDA将Q'Apel Medical Inc.的072抽吸系统（Hippo）全球医疗器械召回及停产分类为I类-动脉网

FDA Classifies Q'Apel Medical Inc.'s Worldwide Medical Device Recall and Discontinuation of its 072 Aspiration System (Hippo) as Class I

CISION 等信源发布 2025-04-19 03:03

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FREMONT, Calif.

加利福尼亚州弗里蒙特

，

April 18, 2025

2025年4月18日

/PRNewswire/ -- On

/PRNewswire/ --

April 7, 2025

2025年4月7日

, the U.S. Food and Drug Administration ('FDA' or 'the agency'), classified Q'Apel Medical, Inc.'s ('Q'Apel' or 'the company') voluntary recall of 1,617 units of its 072 Aspiration System (also known under the product name 'Hippo', which includes 'Cheetah'; collectively, the 'product') as Class I.

美国食品药品监督管理局（“FDA”或“该机构”）将Q'Apel Medical, Inc.（“Q'Apel”或“该公司”）自愿召回的1,617台072抽吸系统（该产品也以“Hippo”这一商品名称销售，其中包括“Cheetah”；统称为“产品”）归类为I类。

开

February 26, 2025

2025年2月26日

, the company initiated a discontinuation and recall of 1,617 units of its 072 Aspiration System product. The recall was initiated because the company received a Warning Letter from FDA that raised questions about whether the features and characteristics of the distal tip of the Hippo aspiration catheter were within the scope of its 510(k) clearance.

公司启动了对其072 Aspiration System产品的1,617个单位的停产和召回。召回的原因是公司收到了FDA的警告信，信中质疑Hippo抽吸导管远端尖端的特性和特征是否在其510(k)许可范围内。

Rather than pursue a new regulatory pathway, the company chose to voluntarily remove all affected product lots and discontinue the 072 Aspiration System line as part of its strategic shift toward newer technologies..

公司没有选择追求新的监管途径，而是自愿撤回所有受影响的产品批次，并作为其向更新技术战略转移的一部分，停止了072抽吸系统产品线。

Q'Apel has submitted three Medical Device Reportable events for the Hippo product to date; these adverse events include a reported tip detachment, retrieved without patient injury; a vessel rupture; and a vasospasm. Based on the company's investigation of these events, factors other than the device's distal tip likely contributed to the reported adverse events..

迄今为止，Q'Apel 已为 Hippo 产品提交了三份医疗器械报告事件；这些不良事件包括报告的尖端脱落（已取回，未造成患者伤害）、血管破裂和血管痉挛。基于公司对这些事件的调查，除了设备远端尖端之外的其他因素可能促成了所报告的不良事件。

Notably, each of these event types is a known risk associated with use of any aspiration catheter and is not unique to the Hippo product. The tip of any aspiration catheter used during a thrombectomy could potentially cause vasospasm and/or vascular injury. In particular, if the tip of an aspiration catheter triggers irritation of the vessel wall, it may manifest as vasospasm, which may be self-limiting or may require treatment (e.g., vasodilatation).

特别地，这些事件类型中的每一个都是与使用任何抽吸导管相关的已知风险，并非 Hippo 产品独有。在血栓切除术中使用的任何抽吸导管的尖端都有可能导致血管痉挛和/或血管损伤。特别是，如果抽吸导管的尖端触发了血管壁的刺激，可能会表现为血管痉挛，这种痉挛可能是自限性的，也可能需要治疗（例如，血管扩张）。

Vascular injury may result in a non-flow limiting dissection that requires no intervention and causes no permanent morbidity, a flow-limiting dissection that requires intervention and may be associated with morbidity, or in the extreme case, vessel perforation or rupture which requires intervention and likely results in morbidity or even mortality.

血管损伤可能导致无需干预且不会造成永久性病态的非血流限制性夹层、需要干预且可能与病态相关的血流限制性夹层，或在极端情况下，血管穿孔或破裂，这需要干预并很可能导致病态甚至死亡。

If unretrieved, a detached tip of a catheter could result in serious adverse events such as blockage of blood vessels, ischemia of end organs, and death..

如果未被取出，导管脱落的尖端可能导致严重不良事件，如血管阻塞、末端器官缺血和死亡。

The product was distributed in

产品已分发至

the United States

美国

，

Qatar

卡塔尔

，

United Arab Emirates

阿拉伯联合酋长国

, and the Republic of

，以及共和国

Kazakhstan

哈萨克斯坦

。

The following product configurations have been removed and discontinued:

以下产品配置已被移除且停止生产：

072 Aspiration System (Hippo with Cheetah Delivery Tool) with Aspiration Tubing; Catalog Number: APT6072-132; Unique Device Identifier: 00857545008127; Lots: FG241008C-03, FG240916C-04, FG240905C-04

072 吸引系统（带猎豹输送工具的河马吸引系统）及吸引管；目录编号：APT6072-132；唯一设备标识符：00857545008127；批次：FG241008C-03，FG240916C-04，FG240905C-04

072 Aspiration System (Hippo with Cheetah Delivery Tool); Catalog Number: AP6072-132; Unique Device Identifier: 00857545008097; Lots: FG241206A-03, FG240917A-01

072 吸引系统（河马与猎豹输送工具）；目录编号：AP6072-132；唯一设备标识符：00857545008097；批次：FG241206A-03，FG240917A-01

072 Aspiration Tubing; Catalog Number: APT-95; Unique Device Identifier: 00857545008103; Lot: FG241206A-04

072 吸引管；目录编号：APT-95；唯一设备标识符：00857545008103；批号：FG241206A-04

Actions to be taken by user:

用户应采取的行动：

The Hippo product configurations described above have been discontinued in all markets. The company has proactively notified all customers and distributors and will continue to monitor the situation closely. Consignees of the product should immediately return any available product inventory to the company.

上述河马产品配置已在所有市场停产。公司已主动通知所有客户和经销商，并将继续密切监控局势。产品的收货人应立即将任何可用的产品库存退还给公司。

If consignees have distributed the product to others, contact Q'Apel so that the company can notify them of this action and retrieve any remaining product..

如果收货人已将产品分发给他人，请联系 Q'Apel，以便公司通知他们此行动并收回任何剩余的产品。

For questions or assistance with product return, please contact:

如有退换商品的问题或需要帮助，请联系：

Q'Apel Medical Inc. – Customer Service

Q'Apel Medical Inc. – 客户服务

Phone: 510-738-6255

电话：510-738-6255

Email:

电子邮件：

orders@qapelmedical.com

Hours: Monday – Friday,

营业时间：周一至周五，

8:00 a.m. to 5:00 p.m. PT

太平洋时间上午8:00至下午5:00

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

使用本产品时遇到的不良反应或质量问题，可以通过在线、普通邮件或传真方式向FDA的MedWatch不良事件报告计划报告。

Complete and submit the report

完成并提交报告

Online

在线

：

www.fda.gov/medwatch/report.htm

Regular Mail or Fax

普通邮件或传真

: Download form

: 下载表格

www.fda.gov/MedWatch/getforms.htm

or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

或拨打1-800-332-1088索取报告表格，然后填写并寄回预先印好的地址，或者传真至1-800-FDA-0178。

About Q'Apel Medical

关于Q'Apel医疗

Q'Apel Medical is revolutionizing neurovascular interventions. Inspired by the evolving needs of our customers, our novel approach allows us to solve clinical challenges where others fall short. We are up for the task, the more complex the better. Our team thrives on creating high quality uniquely engineered products, designed in partnership with neurovascular specialists, that address what is needed right now, yet with the versatility to focus on what is coming next.

Q'Apel Medical正在革新神经血管介入领域。受客户需求的不断变化启发，我们的创新方法使我们能够解决其他公司在临床挑战中未能解决的问题。我们乐于接受任务，越复杂越好。我们的团队专注于创造高质量、独特设计的产品，这些产品与神经血管专家合作设计，不仅满足当前的需求，还具备应对未来需求的灵活性。

For more information, visit .

欲了解更多信息，请访问。

www.qapelmedical.com

。

Media Contact:

媒体联系人:

Charlene Herndon

查琳·赫恩登

SPRIG Consulting

SPRIG咨询公司

charlene@sprigconsulting.com