Class II recall Z-0143-2027: Boston Scientific Corporation
Class II recall Z-0143-2027: Boston Scientific Corporation (Massachusetts): Boston Scientific Corporation. Dated 14 days ago, it is in the active follow-up window. Score 68/100. As of 2026-11-03, from U.S. FDA openFDA (510(k) clearances and device enforcement reports).
Data as of · Compiled by Zalwin from U.S. FDA openFDA (510(k) clearances and device enforcement reports)
Free preview: all 14 published fields of this record are shown below. Locked: 40 related MA FDAPulse records and the 5-column CSV export.
| Field | Value |
|---|---|
| Record | Device recall |
| Recall number | Z-0143-2027 |
| Recalling firm | Boston Scientific Corporation |
| Classification | Class II |
| Status | Ongoing |
| Voluntary / mandated | Voluntary: Firm initiated |
| Specialty | Other |
| Product | NaviFlex LW Pusher; Advx Panc. Stent 4/5F; Material Number (UPN): M00535030; |
| Reason | Device was incorrectly manufactured with a guidewire exit port (referred to in the IFU as the RX port), which is not a design feature associated with this device configuration. |
| Quantity | 403 |
| Distribution | US Nationwide distribution in the states of AL, CA, FL, GA, IL, IN, KY, MD, NC, NH, NM, NY, RI, TX, WA, WI, WV and the countries in TBD. |
| Recall initiated | 2026-09-10 |
| Reported | 2026-10-21 |
| Firm location | Marlborough, MA, United States |
| Peer records CSV (41 MA records) | 🔒 Click to unlock → |
| CRM-ready export with official source URLs | 🔒 Click to unlock → |
Watch Class II recall Z-0143-2027: Boston Scientific Corporation
Free email alert. Alert me when this company gets a new filing, lien, permit, contract or expiry in this feed. One confirmation email; unsubscribe any time.
Free for 1 company. More companies from $9/mo (25), $49/mo (500 + CSV), $199/mo (500 + CSV + API). Cancel any time from the link in every email.
Unlock Class II recall Z-0143-2027: Boston Scientific + all 41 MA records (CSV)
Instant CSV download · Card, Apple Pay, Google Pay or Link via Stripe · No account required
CSV columns: Record · Specialty · Date · Review days · Recall class · official source URL
- Source agency: U.S. FDA openFDA (510(k) clearances and device enforcement reports)
- Record date: 2026-10-21
- Data refreshed: 2026-11-03
- Refunds on request within 14 days
Top FDAPulse records (MA first): GSPE Spacer (K260063) · Sensinel Cardiopulmonary Management (CPM) System (K260801) · multiFiltratePRO System (K261203) · a2z-Abdo-Triage (K260906) · BodyTom 64 (NL4100); OmniTom Elite (NL5000) (K261125) · Browse all by state and category →
LIVE PUBLIC DATA Source: U.S. FDA openFDA (510(k) clearances and device enforcement reports) · Last refreshed: Tue, 03 Nov 2026 18:05:14 GMT
Is this your business? Add a "Listed on Zalwin" badge to your site
Paste this snippet into your website. It links to this public record; nothing is tracked on your site.
Peer benchmark and outreach value: Class II recall Z-0143-2027: Boston Scientific Corporation and 41 Massachusetts peers
- Massachusetts FDAPulse records like this one: 41
- Timing: Medium: dated in the last 30 days
- Estimated pipeline if you contact every Massachusetts peer: $8,200 (peers × rate × deal size; an estimate from your assumptions, not a forecast)
68 / 100 Predicate Speed & CAPA Advisory Opportunity Score
- Class II recall: usually triggers CAPA and quality-system remediation work.
- Recall is still ongoing.
- Posted 14 days ago.
What is the FDAPulse record for Class II recall Z-0143-2027: Boston Scientific Corporation in Massachusetts?
Class II device recall Z-0143-2027 by Boston Scientific Corporation: Device was incorrectly manufactured with a guidewire exit port (referred to in the IFU as the RX port), which is not a d
How does Class II recall Z-0143-2027: Boston Scientific Corporation compare to other Massachusetts FDAPulse records?
It is fresh: dated 14 days ago, inside the window where early outreach matters most.
Class II recall Z-0143-2027 vs. top 3 peers
| Organization | Location | Record date |
|---|---|---|
| Class II recall Z-0143-2027 | MA | 2026-10-21 |
| Class II recall Z-3155-2026 | MA | 2026-10-07 |
| Class II recall Z-0232-2027 | 2026-10-28 | |
| Class II recall Z-0243-2027 | 2026-10-28 |
Related records
- Class II recall Z-3155-2026: Philips North America Llc
- Class II recall Z-0232-2027: Boston Scientific Cork, Ltd.
- Class II recall Z-0243-2027: Boston Scientific Cork, Ltd.
- Class II recall Z-0258-2027: Boston Scientific Cork, Ltd.
- Class II recall Z-0211-2027: Life Technologies Holdings Pte Ltd
- Class II recall Z-0231-2027: Boston Scientific Cork, Ltd.
- Class II recall Z-0197-2027: Medtronic Navigation, Inc.
- Class II recall Z-0281-2027: Medline Industries, LP
- Class II recall Z-0229-2027: Boston Scientific Cork, Ltd.
- Class II recall Z-0196-2027: Medtronic Navigation, Inc.
- Class II recall Z-0275-2027: Medline Industries, LP
- Class II recall Z-0200-2027: Greiner Bio-One North America, Inc.
Recent FDA Class II device recalls
More Massachusetts public-record feeds
FEMA Hazard Mitigation Project Tracker in Massachusetts Nursing Home Inspection Deficiencies by State & Severity in Massachusetts Federal Alcohol Permit Holder Directory in Massachusetts New NIH Research Awards by Organization in Massachusetts New FDA Medical Device Listings by Manufacturer, CMO & Sterilizer in Massachusetts School & Library E-Rate Contracts Up for Rebid in Massachusetts New & Re-Approved E-Rate Service Providers (FCC Form 498 / SPIN) in Massachusetts New FDA PMA Device, NDA, Generic (ANDA), BLA & Drug Supplement Approvals by Sponsor in Massachusetts
How to monitor Class II recall Z-0143-2027: Boston Scientific Corporation and peer other records
Get new FDAPulse records like Class II recall Z-0143-2027: Boston Scientific Corporation by email (free, weekly)
We email one confirmation link now; the weekly digest starts only after you confirm. One-click unsubscribe in every email.
Double opt-in: nothing is sent until you click the confirmation link. One-click unsubscribe.
Get clearances and recalls like this every day
FDAPulse emails new 510(k) clearances and recalls for your specialties and competitors.
✓ Read-only, live public data · Key and unlock right after payment · Card, Apple Pay, Google Pay or Link via Stripe · Refunds on request within 14 days
Data from the FDA openFDA API, which may lag official FDA databases. Informational only; not regulatory or legal advice.
Often used together
- NPIPulse
- EPAPulse
- Municipal Public Works Prime Contract Operating Permit Renewal Pulse
- TrialRecruitmentPageAudit
- SubdomainShadowPulse
- MigrationSignalRadar
Or get the Healthcare Vendor Bundle for $14.99 one-time: Full CSV unlocks for group practices and FDA clearances/recalls.